Histopathology Following CCH Injection

• Sponsor: Endo Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04236635
• Collaborator: (none)
• Enrollment: 10
• Locations: 2
• Arms: 6
• Actual Duration (Months): 10.2
• Patients Per Site: 5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.

Condition or Disease	Intervention/Treatment	Phase
Characteristics of Subcutaneous Tissue	Drug: Collagenase Clostridium Histolyticum Single Injection Technique; Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model
• Actual Study Start Date: Dec 20, 2019
• Actual Primary Completion Date: Sep 23, 2020
• Actual Study Completion Date: Oct 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: CCH Single Injection Technique Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.	Drug: Collagenase Clostridium Histolyticum Single Injection Technique; CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.; Other Names: EN3835 CCH
Experimental: Group 2: CCH Single Injection Technique Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.	Drug: Collagenase Clostridium Histolyticum Single Injection Technique; CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.; Other Names: EN3835 CCH
Experimental: Group 3: CCH Single Injection Technique Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.	Drug: Collagenase Clostridium Histolyticum Single Injection Technique; CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.; Other Names: EN3835 CCH
Experimental: Group 4: CCH Multiple Injection Technique Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.	Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique; CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.; Other Names: EN3835 CCH
Experimental: Group 5: CCH Multiple Injection Technique Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.	Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique; CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.; Other Names: EN3835 CCH
Experimental: Group 6: CCH Multiple Injection Technique Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.	Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique; CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.; Other Names: EN3835 CCH

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH [Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)]

   Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in tissue dosed with CCH relative to control tissue (tissue not dosed with CCH) is reported.

Secondary Outcome Measures

1. Number of Participants With a Histologic Change in a Tissue Specimen After 2 CCH Dose Injections Relative to a Tissue Specimen After 1 CCH Dose Injection [Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)]

   Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in a tissue specimen injected with 2 CCH dose injections (Treatment Area 1) relative to 1 CCH dose injection (Treatment Area 2) is reported.

2. Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment [End of Study (Day 28)]

   Serum samples were analyzed for anti-AUX-I clostridial class I collagenase of ADAs and anti-AUX-II Clostridial class II collagenase of ADAs. The number of participants who developed anti-AUX-I and anti-AUX-II ADAs (positive ADA result) are reported.

3. Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment [End of Study (Day 28)]

   Serum samples were analyzed for anti-AUX-I and Anti-AUX-II Nabs. The number of participants who developed anti-AUX-I and Anti-AUX-II NAbs (positive NAb results) are reported. Neutralizing antibodies were only tested from ADA positive participants.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Be adequately informed and understand the nature and risks of the study and be able to provide consent.

2. Be undergoing planned elective abdominoplasty.

3. Be willing to have their tissue donated for evaluation.

4. Be judged to be in good health.

5. Have a negative pregnancy test.

6. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

2. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.

3. Has local (in the areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.

4. Required use of anticoagulant or antiplatelet medication (except ≤ 150 mg aspirin daily) before or during participation in the trial.

5. Past history of any abdominal surgery, including but not limited to: liposuction, caesarean section, appendectomy, cholecystectomy, or umbilical hernia repair.

6. Has used or intends to use any local applications/therapies/injections/procedures that restricts study participation.

7. Is presently nursing or providing breast milk in any manner.

8. Intends to become pregnant during the study.

9. Intends to initiate an intensive sport or exercise program regimen during the study.

10. Intends to use any tanning spray or tanning booths during the study.

11. Has received any investigational drug or treatment within 30 days prior to first injection of study drug.

12. Has a known systemic allergy to collagenase or any other excipient of study drug.

13. Has received any collagenase treatment at any time prior to treatment in this study.

14. Any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endo Clinical Trial Site #1	Montclair	New Jersey	United States	07042
2	Endo Clinical Trial Site #2	New York	New York	United States	10021

Sponsors and Collaborators

• Endo Pharmaceuticals

Investigators

• Study Director: Karen Chajko, Endo Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol - May 1, 2020
• Statistical Analysis Plan - Jun 26, 2020

More Information

Publications

None provided.

• Responsible Party: Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04236635
• Other Study ID Numbers: EN3835-213
• First Posted: Jan 22, 2020
• Last Update Posted: Apr 12, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Pre-assignment Detail	Participants were divided among 6 different cohorts based on injection technique and respective dosing days. Two participants (Group 4 multiple injection technique) were not included in the Evaluable Population when their surgeries were delayed due to the effects of COVID-19 restrictions.

Arm/Group Title	Group 1: Collagenase Clostridium Histolyticum (CCH) Single Injection Technique	Group 2: CCH Single Injection Technique	Group 3: CCH Single Injection Technique	Group 4: CCH Multiple Injection Technique	Group 5: CCH Multiple Injection Technique	Group 6: CCH Multiple Injection Technique
Arm/Group Description	Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique. Each participant had 2 marked areas of the abdomen (Area 1 and Area 2) selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.	Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.	Participants were administered 0.07 mg CCH using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.	Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.	Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.	Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
Period Title: Overall Study
STARTED	2	1	1	4	1	1
Safety Population	2	1	1	4	1	1
Evaluable Population	2	1	1	2	1	1
COMPLETED	2	1	1	4	1	1
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	CCH Subcutaneous Injection
Arm/Group Description	Participants were administered 0.07 mg CCH using a single injection technique or 0.0653 mg CCH using a multiple injection technique.
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.1 (10.55)
Sex: Female, Male (Count of Participants)
Female	10 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 20%
Not Hispanic or Latino	8 80%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 40%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	5 50%
More than one race	0 0%
Unknown or Not Reported	1 10%
Weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	71.31 (16.275)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	164.47 (7.265)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.24 (4.460)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH
Description	Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in tissue dosed with CCH relative to control tissue (tissue not dosed with CCH) is reported.
Time Frame	Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)

Outcome Measure Data

Analysis Population Description

Evaluable Population: All participants who received at least 1 injection of study drug, underwent abdominoplasty within the protocol specified timelines, and had a histopathology and immunohistochemistry report.

Arm/Group Title	Group 1: CCH Single Injection Technique	Group 2: CCH Single Injection Technique	Group 3: CCH Single Injection Technique	Group 4: CCH Multiple Injection Technique	Group 5: CCH Multiple Injection Technique	Group 6: CCH Multiple Injection Technique
Arm/Group Description	Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.	Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.	Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.	Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.	Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.	Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
Measure Participants	2	1	1	2	1	1
Count of Participants [Participants]	2 20%	1 NaN	1 NaN	2 NaN	1 NaN	1 NaN

2. Secondary Outcome

Title	Number of Participants With a Histologic Change in a Tissue Specimen After 2 CCH Dose Injections Relative to a Tissue Specimen After 1 CCH Dose Injection
Description	Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in a tissue specimen injected with 2 CCH dose injections (Treatment Area 1) relative to 1 CCH dose injection (Treatment Area 2) is reported.
Time Frame	Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)

Outcome Measure Data

Analysis Population Description

Evaluable Population: All participants who received at least 1 injection of study drug, underwent abdominoplasty within the protocol specified timelines, and had a histopathology and immunohistochemistry report.

Arm/Group Title	Group 1: CCH Single Injection Technique	Group 2: CCH Single Injection Technique	Group 3: CCH Single Injection Technique	Group 4: CCH Multiple Injection Technique	Group 5: CCH Multiple Injection Technique	Group 6: CCH Multiple Injection Technique
Arm/Group Description	Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.	Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.	Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.	Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.	Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.	Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
Measure Participants	2	1	1	2	1	1
Count of Participants [Participants]	2 20%	1 NaN	1 NaN	2 NaN	1 NaN	1 NaN

3. Secondary Outcome

Title	Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment
Description	Serum samples were analyzed for anti-AUX-I clostridial class I collagenase of ADAs and anti-AUX-II Clostridial class II collagenase of ADAs. The number of participants who developed anti-AUX-I and anti-AUX-II ADAs (positive ADA result) are reported.
Time Frame	End of Study (Day 28)

Outcome Measure Data

Analysis Population Description

Safety Population: All participants who received at least 1 injection of study drug irrespective of the timing window of abdominoplasty. ADA data is reported as overall population instead of individual groups due to the small number of participants per arm and to protect PII of the participants.

Arm/Group Title	CCH Subcutaneous Injection
Arm/Group Description	Participants were administered 0.07 mg CCH using a single injection technique or 0.0653 mg CCH using a multiple injection technique.
Measure Participants	10
Anti-AUX-I ADAs	9 90%
Anti-AUX-II ADAs	5 50%

4. Secondary Outcome

Title	Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment
Description	Serum samples were analyzed for anti-AUX-I and Anti-AUX-II Nabs. The number of participants who developed anti-AUX-I and Anti-AUX-II NAbs (positive NAb results) are reported. Neutralizing antibodies were only tested from ADA positive participants.
Time Frame	End of Study (Day 28)

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 injection of study drug and were positive for ADAs. NAb data is reported as overall analysis population instead of individual groups due to the small number of participants per arm and to protect PII of the participants.

Arm/Group Title	CCH Subcutaneous Injection
Arm/Group Description	Participants were administered 0.07 mg CCH using a single injection technique or 0.0653 mg CCH using a multiple injection technique.
Measure Participants	9
Anti-AUX-I NAbs	7 70%
Anti-AUX-II NAbs	3 30%

Adverse Events

Time Frame	From first injection (earliest dosing visit at Day -43) up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) for CCH injection treatment and up to end of study (Day 28 post-abdominoplasty surgery follow-up visit)
Adverse Event Reporting Description	Adverse events were collected throughout the study (up to Day 28 post-abdominoplasty surgery follow-up visit). Adverse events associated with local tolerability in treatment areas injected with CCH were collected up to the day abdominal tissue was excised.
Arm/Group Title	Group 1: CCH Single Injection Technique		Group 2: CCH Single Injection Technique		Group 3: CCH Single Injection Technique		Group 4: CCH Multiple Injection Technique		Group 5: CCH Multiple Injection Technique		Group 6: CCH Multiple Injection Technique
Arm/Group Description	Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.		Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.		Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.		Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked (Area 1 and Area 2) areas of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.		Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.		Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
All Cause Mortality
	Group 1: CCH Single Injection Technique		Group 2: CCH Single Injection Technique		Group 3: CCH Single Injection Technique		Group 4: CCH Multiple Injection Technique		Group 5: CCH Multiple Injection Technique		Group 6: CCH Multiple Injection Technique
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)		0/1 (0%)		0/4 (0%)		0/1 (0%)		0/1 (0%)
Serious Adverse Events
	Group 1: CCH Single Injection Technique		Group 2: CCH Single Injection Technique		Group 3: CCH Single Injection Technique		Group 4: CCH Multiple Injection Technique		Group 5: CCH Multiple Injection Technique		Group 6: CCH Multiple Injection Technique
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)		0/1 (0%)		0/4 (0%)		0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: CCH Single Injection Technique		Group 2: CCH Single Injection Technique		Group 3: CCH Single Injection Technique		Group 4: CCH Multiple Injection Technique		Group 5: CCH Multiple Injection Technique		Group 6: CCH Multiple Injection Technique
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		1/1 (100%)		1/1 (100%)		4/4 (100%)		1/1 (100%)		1/1 (100%)
Gastrointestinal disorders
Abdominal hernia	0/2 (0%)		1/1 (100%)		0/1 (0%)		1/4 (25%)		0/1 (0%)		1/1 (100%)
General disorders
Injection site oedema	0/2 (0%)		0/1 (0%)		0/1 (0%)		2/4 (50%)		0/1 (0%)		0/1 (0%)
Injection site bruising	1/2 (50%)		1/1 (100%)		1/1 (100%)		3/4 (75%)		0/1 (0%)		0/1 (0%)
Injection site pain	2/2 (100%)		0/1 (0%)		0/1 (0%)		4/4 (100%)		1/1 (100%)		1/1 (100%)
Injection site haemorrhage	2/2 (100%)		0/1 (0%)		0/1 (0%)		1/4 (25%)		0/1 (0%)		0/1 (0%)
Infections and infestations
Urinary tract infection	1/2 (50%)		0/1 (0%)		0/1 (0%)		0/4 (0%)		0/1 (0%)		0/1 (0%)
Injury, poisoning and procedural complications
Post procedural swelling	1/2 (50%)		1/1 (100%)		0/1 (0%)		0/4 (0%)		1/1 (100%)		0/1 (0%)
Procedural pain	2/2 (100%)		1/1 (100%)		1/1 (100%)		4/4 (100%)		1/1 (100%)		1/1 (100%)
Postoperative wound infection	0/2 (0%)		1/1 (100%)		0/1 (0%)		0/4 (0%)		0/1 (0%)		0/1 (0%)
Post procedural erythema	1/2 (50%)		0/1 (0%)		0/1 (0%)		0/4 (0%)		0/1 (0%)		0/1 (0%)
Post procedural oedema	1/2 (50%)		0/1 (0%)		1/1 (100%)		4/4 (100%)		0/1 (0%)		1/1 (100%)
Abdominal wound dehiscence	1/2 (50%)		0/1 (0%)		0/1 (0%)		1/4 (25%)		0/1 (0%)		0/1 (0%)
Post procedural contusion	0/2 (0%)		0/1 (0%)		0/1 (0%)		1/4 (25%)		0/1 (0%)		0/1 (0%)
Nervous system disorders
Hypoaesthesia	1/2 (50%)		1/1 (100%)		1/1 (100%)		4/4 (100%)		1/1 (100%)		1/1 (100%)
Skin and subcutaneous tissue disorders
Ecchymosis	2/2 (100%)		1/1 (100%)		1/1 (100%)		3/4 (75%)		1/1 (100%)		1/1 (100%)
Umbilical erythema	0/2 (0%)		0/1 (0%)		0/1 (0%)		1/4 (25%)		0/1 (0%)		0/1 (0%)
Vascular disorders
Hypertension	1/2 (50%)		0/1 (0%)		0/1 (0%)		0/4 (0%)		0/1 (0%)		1/1 (100%)

Limitations/Caveats

This was considered an exploratory study by the Sponsor. No formal sample size calculations were performed. Completion of 8 participants provided minimal data to meet the primary objective in the evaluable population.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.