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Global Prospective Case Series Using a Single-Use Duodenoscope

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04103749
Collaborator
(none)
1,000
Enrollment
21
Locations
1
Arm
20.3
Anticipated Duration (Months)
47.6
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

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

Detailed Description

This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. Up to 1000 cases will be included at up to 40 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 30 days after their procedure.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Global Prospective Case Series Using a Single-Use Duodenoscope
Actual Study Start Date :
Mar 22, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exalt DScope 02

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.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants with successful 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 rating [Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.]

    Endoscopist rating of the Exalt single-use duodenoscope compared to their past experience with marketed reusable duodenoscopes as it pertains to various design and performance related attributes, recorded on two Likert scales of different ranges. The maneuverability and performance related attributes will be rated on a scale from 1 (worst) to 10 (best).

  2. Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscope [Incidence of 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. Rate of adverse events (SAEs) related to the device and/or the procedure [SAEs are assessed through 30 days after 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 ERCP

Exclusion Criteria:

  • 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 University of Chicago Chicago Illinois United States 60637
3 Indianapolis University Hospital Indianapolis Indiana United States 46202
4 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
5 Mayo Clinic Rochester Minnesota United States 55905
6 North Shore University Hospital Manhasset New York United States 11030
7 Cornell Medical Center New York New York United States 10065
8 Cleveland Clinic Cleveland Ohio United States 44195
9 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
10 The University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
11 Virginia Mason Medical Center Seattle Washington United States 98101
12 Metro North Hospital and Health Services Brisbane Australia
13 St. Michael's Hospital - Unity Health Toronto Canada M5B 1W8
14 Evangelisches Krankenhaus Düsseldorf Düsseldorf North Rhine-Westphalia Germany
15 Prince of Wales Hospital Hong Kong Hong Kong
16 Asian Institute of Gastroenterology Hyderabad Telangana India
17 Apollo Multispeciality Hospitals Kolkata West Bengal India 700054
18 Humanitas University Milan Italy
19 Erasmus University Medical Center of Rotterdam Rotterdam Netherlands 3015 CN
20 Singapore General Hospital Singapore Singapore
21 Dr. George Mukhari Academic Hospital Ga-Rankuwa South Africa

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT04103749
Other Study ID Numbers:
  • E7156
First Posted:
Sep 25, 2019
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
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
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Aug 19, 2022