EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

• Sponsor: Interscope, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03694210
• Collaborator: (none)
• Enrollment: 30
• Locations: 10
• Arm: 1
• Actual Duration (Months): 9.2
• Patients Per Site: 3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off pancreatic necrosis (WOPN).

Condition or Disease	Intervention/Treatment	Phase
Acute Pancreatic Necrosis; Acute Pancreatitis; Necrotizing Pancreatitis	Device: EndoRotor Therapy	N/A

Detailed Description

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN). Total enrollment 30 subjects with at least 15 enrolled in the US.

Subjects will be debrided with the EndoRotor either at the time of stent placement or post placement at Investigator's discretion with a maximum of 4 EndoRotor procedures. A minimum of 2 days is required between each EndoRotor procedure and all procedures need to be completed within a 14 (+7/-0) day period. Follow up is completed 21 (+/- 7) days after last EndoRotor debridement procedure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN).A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis
• Actual Study Start Date: Nov 15, 2018
• Actual Primary Completion Date: Aug 22, 2019
• Actual Study Completion Date: Aug 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EndoRotor Therapy Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.	Device: EndoRotor Therapy; To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.

Outcome Measures

Primary Outcome Measures

1. Safety: Number of Participants With Device Related Complications [21 +/- 7 Days]

   The primary endpoint of this study is the freedom from major device related complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding.

Secondary Outcome Measures

1. Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed [21 +/- 7 Days]

   Successful clearance of necrosis in the collection being treated during direct endoscopic necrosectomy where success is defined as at least 70% of the necrotic debris in the collection being treated is removed based on CT evaluation of the cavity at the 21 (+/-7) day follow up visit.

2. Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis [Completion of all necrosectomy procedures per patient]

   Assessment of total procedure time to achieve clearance of necrosis for all procedures. Total procedure time is measured from scope-in to scope-out. EndoRotor time is measured from the start of EndoRotor use to the end of EndoRotor use.

3. Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure. [This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated.]

   At the completion of each necrosectomy procedure the Investigator will visually inspect the WOPN cavity endoscopically and estimate the percent of necrosis that was removed from the cavity using EndoRotor. For each procedure, the initial amount of necrosis in the WOPN cavity is considered 100%.

4. Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis. [This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated.]

   The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed.

5. Mean Length of Hospital Stay Per Participant [At patient discharge from hospital]

   The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge.

6. Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score [21 +/- 7 Days]

   The SF-36v1 questionnaire measures functional health and well-being from a patient's point of view. The questionnaire assess eight health domains including: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well Being, Social Functioning, Pain, and General Health. Participants were asked to complete the questionnaire at the Baseline Visit and then again at the 21 Day Post Necrosectomy Follow-up Visit. The results of the questionnaire from the 21 Day Post Necrosectomy Follow-up Visit were then compared to those of Baseline for improvement. Numeric scores for each health domain are reported on a scale of 0-100 with improvement demonstrated by a higher score than baseline. Statistically significant improvement is denoted by differences in Baseline and 21 Day Follow-up Visit scores that have a p-value < 0.05.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects who are >22; inclusive of males and females.

2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage

3. Imaging suggestive of greater than or equal to 30% necrotic material

4. Walled off pancreatic necrosis size ≥6 cm and ≤22cm

5. Subject can tolerate repeated endoscopic procedures

6. Subject capable of giving informed consent.

7. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7) days, as indicated.

Exclusion Criteria:

1. Subject unable to give informed consent.

2. Subject is unwilling to return for repeated endoscopies.

3. Documented Pseudoaneurysm > 1cm within the WOPN

4. Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound).

5. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure

6. Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).

7. Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.

8. Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benjamin Tharian	Little Rock	Arkansas	United States	72205
2	Stanford University Medical Center	Palo Alto	California	United States	94304
3	California Pacific Medical Center - Sutter Health	San Francisco	California	United States	94115
4	University of Chicago Department of Medicine	Chicago	Illinois	United States	60637
5	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901
6	Arvin Trindade	Queens	New York	United States	11040
7	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
8	University of Frankfurt Medicine	Frankfurt		Germany	60590
9	Interdisciplinary Clinic for Endoscopy - TU Munich	München		Germany	81675
10	Erasmus Medical Center	Rotterdam		Netherlands	3015 CE

Sponsors and Collaborators

• Interscope, Inc.

Investigators

• Principal Investigator: Marco Bruno, MD PhD, Erasmus Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 31, 2018

More Information

Publications

None provided.

• Responsible Party: Interscope, Inc.
• ClinicalTrials.gov Identifier: NCT03694210
• Other Study ID Numbers: CLIN-0047
• First Posted: Oct 3, 2018
• Last Update Posted: Nov 2, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Interscope, Inc.: Direct Endoscopic Necrosectomy; Walled Off Necrosis; Walled Off Pancreatic Necrosis
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Acute Necrotizing; Necrosis

Study Results

Participant Flow

Recruitment Details	Enrollment Dates: November 2018 to August 2019

Arm/Group Title	EndoRotor Therapy
Arm/Group Description	Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Period Title: Overall Study
STARTED	37
COMPLETED	29
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	EndoRotor Therapy
Arm/Group Description	Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.7 (15.5)
Sex: Female, Male (Count of Participants)
Female	12 40%
Male	18 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 13.3%
Not Hispanic or Latino	20 66.7%
Unknown or Not Reported	6 20%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 10%
White	17 56.7%
More than one race	0 0%
Unknown or Not Reported	10 33.3%
Region of Enrollment (participants) [Number]
Netherlands	2 6.7%
United States	23 76.7%
Germany	5 16.7%
Cause of Pancreatitis (Count of Participants)
Gallstone/biliary	18 60%
Alcohol	5 16.7%
Unknown Cause	7 23.3%

Outcome Measures

1. Primary Outcome

Title	Safety: Number of Participants With Device Related Complications
Description	The primary endpoint of this study is the freedom from major device related complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding.
Time Frame	21 +/- 7 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRotor Therapy
Arm/Group Description	Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Measure Participants	30
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed
Description	Successful clearance of necrosis in the collection being treated during direct endoscopic necrosectomy where success is defined as at least 70% of the necrotic debris in the collection being treated is removed based on CT evaluation of the cavity at the 21 (+/-7) day follow up visit.
Time Frame	21 +/- 7 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRotor Therapy
Arm/Group Description	Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Measure Participants	30
Count of Participants [Participants]	29 96.7%

3. Secondary Outcome

Title	Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis
Description	Assessment of total procedure time to achieve clearance of necrosis for all procedures. Total procedure time is measured from scope-in to scope-out. EndoRotor time is measured from the start of EndoRotor use to the end of EndoRotor use.
Time Frame	Completion of all necrosectomy procedures per patient

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRotor Therapy
Arm/Group Description	Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Measure Participants	30
Total Procedure Time	117 (50)
EndoRotor Time	71 (37)

4. Secondary Outcome

Title	Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.
Description	At the completion of each necrosectomy procedure the Investigator will visually inspect the WOPN cavity endoscopically and estimate the percent of necrosis that was removed from the cavity using EndoRotor. For each procedure, the initial amount of necrosis in the WOPN cavity is considered 100%.
Time Frame	This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRotor Therapy
Arm/Group Description	Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Measure Participants	30
Mean (Standard Deviation) [% Necrosis removed for all procedures]	60 (33)

5. Secondary Outcome

Title	Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.
Description	The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed.
Time Frame	This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EndoRotor Therapy
Arm/Group Description	Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Measure Participants	30
Mean (Standard Deviation) [Procedures]	2 (2)

6. Secondary Outcome

Title	Mean Length of Hospital Stay Per Participant
Description	The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge.
Time Frame	At patient discharge from hospital

Outcome Measure Data

Analysis Population Description

Patients with outpatient visits were assigned 0.5 days conservatively

Arm/Group Title	EndoRotor Therapy
Arm/Group Description	Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Measure Participants	30
Mean (Standard Deviation) [Days]	18 (25)

7. Secondary Outcome

Title	Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
Description	The SF-36v1 questionnaire measures functional health and well-being from a patient's point of view. The questionnaire assess eight health domains including: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well Being, Social Functioning, Pain, and General Health. Participants were asked to complete the questionnaire at the Baseline Visit and then again at the 21 Day Post Necrosectomy Follow-up Visit. The results of the questionnaire from the 21 Day Post Necrosectomy Follow-up Visit were then compared to those of Baseline for improvement. Numeric scores for each health domain are reported on a scale of 0-100 with improvement demonstrated by a higher score than baseline. Statistically significant improvement is denoted by differences in Baseline and 21 Day Follow-up Visit scores that have a p-value < 0.05.
Time Frame	21 +/- 7 Days

Outcome Measure Data

Analysis Population Description

All participants who had a completed SF-36v1 Questionnaire at both Baseline and the 21 Day Follow-up visit.

Arm/Group Title	Baseline SF-36v1 Score	21 Day Post Necrosectomy SF-36v1 Score
Arm/Group Description	Baseline SF-36v1 results for 8 domains	21 Day Post Necrosectomy SF-36v1 results for 8 domains
Measure Participants	24	24
Physical Functioning	36.0 (30.8)	57.3 (30.8)
Role Limitations due to Physical Health	11.4 (28.5)	25.0 (37.6)
Role Limitations due to Emotional Problems	27.8 (41.3)	51.4 (48.1)
Energy / Fatigue	27.9 (22.0)	36.7 (23.2)
Emotional Well Being	60.7 (19.7)	68.3 (18.9)
Social Functioning	51.6 (32.6)	56.3 (26.6)
Pain	31.4 (28.4)	56.0 (30.1)
General Health	47.8 (15.9)	53.8 (15.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EndoRotor Therapy, 21 Day Post Necrosectomy SF-36v1 Score
	Comments	Physical Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0011
	Comments	p-values of <0.05 are considered significant.
	Method	Wilcoxon Signed Rank Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EndoRotor Therapy, 21 Day Post Necrosectomy SF-36v1 Score
	Comments	Role Limitations due to Physical Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1152
	Comments	p-values of <0.05 are considered significant
	Method	Wilcoxon Signed Rank Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EndoRotor Therapy, 21 Day Post Necrosectomy SF-36v1 Score
	Comments	Role Limitations due to Emotional Problems: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0552
	Comments	p-values of <0.05 are considered significant
	Method	Wilcoxon Signed Rank Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EndoRotor Therapy, 21 Day Post Necrosectomy SF-36v1 Score
	Comments	Energy/Fatigue: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.039
	Comments	p-values of <0.05 are considered significant
	Method	Wilcoxon Signed Rank Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EndoRotor Therapy, 21 Day Post Necrosectomy SF-36v1 Score
	Comments	Emotional Well Being: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0223
	Comments	p-values of <0.05 are considered significant
	Method	Wilcoxon Signed Rank Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	EndoRotor Therapy, 21 Day Post Necrosectomy SF-36v1 Score
	Comments	Social Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4664
	Comments	p-values of <0.05 are considered significant
	Method	Wilcoxon Signed Rank Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	EndoRotor Therapy, 21 Day Post Necrosectomy SF-36v1 Score
	Comments	Pain: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	p-values of <0.05 are considered significant
	Method	Wilcoxon Signed Rank Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	EndoRotor Therapy, 21 Day Post Necrosectomy SF-36v1 Score
	Comments	General Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0639
	Comments	p-values of <0.05 are considered significant
	Method	Wilcoxon Signed Rank Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse Events were captured from Index Procedure through 21 day Follow-up
Arm/Group Title	EndoRotor Therapy
Arm/Group Description	Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. EndoRotor Therapy: To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
All Cause Mortality
	EndoRotor Therapy
	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)
Serious Adverse Events
	EndoRotor Therapy
	Affected / at Risk (%)	# Events
Total	9/30 (30%)
Gastrointestinal disorders
Hematemesis	1/30 (3.3%)	1
Gastrointestinal Bleed	2/30 (6.7%)	2
General disorders
Multiple Organ Failure Syndrome	1/30 (3.3%)	1
Hepatobiliary disorders
Cholestasis	1/30 (3.3%)	1
Pancreatitis	1/30 (3.3%)	1
Infections and infestations
Sepsis	1/30 (3.3%)	1
Surgical and medical procedures
Pneumoperitoneum	1/30 (3.3%)	1
Vascular disorders
Deep Vein Thrombosis	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	EndoRotor Therapy
	Affected / at Risk (%)	# Events
Total	11/30 (36.7%)
Gastrointestinal disorders
Colitis	1/30 (3.3%)	1
Diarrhea	1/30 (3.3%)	1
Esophageal Candidiasis	1/30 (3.3%)	1
General disorders
Pyrexia	1/30 (3.3%)	1
Infections and infestations
Bacteremia	1/30 (3.3%)	1
Clostridium Difficile Infection	1/30 (3.3%)	1
Metabolism and nutrition disorders
Hypokalemia	1/30 (3.3%)	1
Nervous system disorders
Insomnia	1/30 (3.3%)	1
Product Issues
Device Dislocation (LAMS dislodgement)	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	1/30 (3.3%)	1
Vascular disorders
Anemia	1/30 (3.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

At least sixty days before publication submission PI shall submit to Sponsor for review and comment. PI will consider comments, but is not obligated to incorporate suggestions. Publication shall acknowledge Sponsor contributions as appropriate. Investigator agrees that first publication of results shall be a joint, multicenter publication, with the investigators and the institutions from all appropriate sites contributing data, analyses and comments.