Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04223830
• Collaborator: (none)
• Enrollment: 200
• Locations: 7
• Arm: 1
• Actual Duration (Months): 13.5
• Patients Per Site: 28.6
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography	Device: Exalt Model D Single-Use Duodenoscope	N/A

Detailed Description

The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience
• Actual Study Start Date: Jan 14, 2020
• Actual Primary Completion Date: Feb 22, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exalt DScope 01B Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.	Device: Exalt Model D Single-Use Duodenoscope; Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure [Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).]

   The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.

Secondary Outcome Measures

1. Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope [Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.]

   Endoscopist overall satisfaction rating of the Exalt single-use duodenoscope, as compared to their past experience with marketed reusable duodenoscopes. The overall satisfaction rating is recorded on a scale of 1 (unsatisfied) to 10 (very satisfied), with 1 being the minimum value (worse) and 10 being the maximum value (better). A rating of 1 indicates the endoscopist is unsatisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. A rating of 10 indicates the endoscopist is very satisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes.

2. Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope [Crossover is monitored throughout the procedure (within 24 hours on study day 1).]

   The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover.

3. Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure [SAEs are assessed through 7 days after the procedure.]

   Number of serious adverse events (SAEs) related to the device and/or the procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older

• Willing and able to comply with the study procedures and provide written informed consent to participate in the study

• Scheduled for a clinically indicated endoscopic retrograde cholangiopancreatography (ERCP)

Exclusion Criteria:

• Altered pancreaticobiliary anatomy

• Potentially vulnerable subjects, including, but not limited to pregnant women

• Subjects for whom endoscopic techniques are contraindicated

• Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor

• Investigator discretion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles Medical Center	Los Angeles	California	United States	90095
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
3	Mayo Clinic	Rochester	Minnesota	United States	55902
4	North Shore University Hospital	Manhasset	New York	United States	11030
5	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
6	Virginia Mason Medical Center	Seattle	Washington	United States	98101
7	Erasmus Medical Center	Rotterdam		Netherlands

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Adam Slivka, MD, PhD, University of Pittsburgh Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 13, 2020

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT04223830
• Other Study ID Numbers: E7158
• First Posted: Jan 10, 2020
• Last Update Posted: Mar 31, 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: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Pre-assignment Detail	208 patients provided informed consent for the study, however prior to participation 8 patients were subsequently found to be ineligible and are considered screen failures per protocol.

Arm/Group Title	Exalt DScope 01B
Arm/Group Description	Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form. Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
Period Title: Overall Study
STARTED	200
COMPLETED	190
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Exalt DScope 01B
Arm/Group Description	Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form. Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
Overall Participants	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.6 (14.0)
Sex: Female, Male (Count of Participants)
Female	103 51.5%
Male	97 48.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Netherlands	10 5%
United States	190 95%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
Description	The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.
Time Frame	Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exalt DScope 01B
Arm/Group Description	Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form. Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
Measure Participants	200
Count of Participants [Participants]	193 96.5%

2. Secondary Outcome

Title	Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope
Description	Endoscopist overall satisfaction rating of the Exalt single-use duodenoscope, as compared to their past experience with marketed reusable duodenoscopes. The overall satisfaction rating is recorded on a scale of 1 (unsatisfied) to 10 (very satisfied), with 1 being the minimum value (worse) and 10 being the maximum value (better). A rating of 1 indicates the endoscopist is unsatisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. A rating of 10 indicates the endoscopist is very satisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes.
Time Frame	Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exalt DScope 01B
Arm/Group Description	Overall satisfaction
Measure Participants	200
Mean (Standard Deviation) [score on a scale]	7.6 (2.1)

3. Secondary Outcome

Title	Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope
Description	The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover.
Time Frame	Crossover is monitored throughout the procedure (within 24 hours on study day 1).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exalt DScope 01B
Arm/Group Description	Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form. Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
Measure Participants	200
Count of Participants [Participants]	19 9.5%

4. Secondary Outcome

Title	Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure
Description	Number of serious adverse events (SAEs) related to the device and/or the procedure.
Time Frame	SAEs are assessed through 7 days after the procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exalt DScope 01B
Arm/Group Description	Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form. Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
Measure Participants	200
Number [Related Serious Adverse Events]	15

Adverse Events

Time Frame	Occurrence of adverse events were collected through 7 days (+/- 2 days) after the index procedure.
Adverse Event Reporting Description	All adverse events were collected, regardless of relationship to study device and/or procedure. Given the nature of the study procedure, any crossover between the Exalt single-use duodenoscope and the reusable duodenoscope would have occurred during the same study procedure therefore, it is difficult to determine the relatedness of adverse events to the Exalt single-use duodenoscope or to the reusable duodenoscope. Adverse events are therefore reported in a combined fashion.
Arm/Group Title	Exalt DScope 01B
Arm/Group Description	Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form. Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
All Cause Mortality
	Exalt DScope 01B
	Affected / at Risk (%)	# Events
Total	0/200 (0%)
Serious Adverse Events
	Exalt DScope 01B
	Affected / at Risk (%)	# Events
Total	13/200 (6.5%)
Gastrointestinal disorders
Abdominal pain	2/200 (1%)	2
Vomiting	1/200 (0.5%)	1
Pancreatitis	3/200 (1.5%)	3
Oesophageal mucosal tear	1/200 (0.5%)	1
Gastrointestinal hemorrhage	1/200 (0.5%)	1
Mallory-Weiss syndrome	1/200 (0.5%)	1
General disorders
Systemic inflammatory response syndrome	1/200 (0.5%)	1
Hepatobiliary disorders
Bile duct stone	1/200 (0.5%)	1
Cholangitis	2/200 (1%)	2
Infections and infestations
Pneumonia	1/200 (0.5%)	1
Escherichia urinary tract infection	1/200 (0.5%)	1
Fever	1/200 (0.5%)	1
Injury, poisoning and procedural complications
Post procedural haemorrhage	2/200 (1%)	2
Other (Not Including Serious) Adverse Events
	Exalt DScope 01B
	Affected / at Risk (%)	# Events
Total	20/200 (10%)
Eye disorders
Conjunctival haemorrhage	1/200 (0.5%)	1
Gastrointestinal disorders
Abdominal Pain	8/200 (4%)	8
Pancreatitis	5/200 (2.5%)	5
Diarrhoea	2/200 (1%)	2
Nausea	1/200 (0.5%)	1
Haematochezia	1/200 (0.5%)	1
Dysphagia	1/200 (0.5%)	1
Dyspepsia	1/200 (0.5%)	1
Abnormal faeces	1/200 (0.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.