Global Prospective Case Series Using a Single-Use Duodenoscope

Not Applicable

Completed

Conditions: Endoscopic Retrograde Cholangiopancreatography

Interventions: Device: Exalt Model D Single-Use Duodenoscope

Registration Number: NCT04103749

Lead Sponsor: Boston Scientific Corporation

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 551

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exalt DScope 02	Exalt Model D Single-Use Duodenoscope	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best)
Number of Participants With a 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.
Number of Adverse Events (SAEs) Related to the Device and/or the Procedure	SAEs are assessed through 30 days after the procedure.	Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or other duodenoscope based procedures

Trial Locations

Locations (22): University of Chicago
🇺🇸
Chicago, Illinois, United States
Evangelisches Krankenhaus Düsseldorf
🇩🇪
Düsseldorf, North Rhine-Westphalia, Germany
Singapore General Hospital
🇸🇬
Singapore, Singapore
Apollo Multispeciality Hospitals
🇮🇳
Kolkata, West Bengal, India
Indianapolis University Hospital
🇺🇸
Indianapolis, Indiana, United States
University of California Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Erasmus University Medical Center of Rotterdam
🇳🇱
Rotterdam, Netherlands
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
St. Michael's Hospital - Unity Health
🇨🇦
Toronto, Canada
Humanitas University
🇮🇹
Milan, Italy
Asian Institute of Gastroenterology
🇮🇳
Hyderabad, Telangana, India
Prince of Wales Hospital
🇭🇰
Hong Kong, Hong Kong
North Shore University Hospital
🇺🇸
Manhasset, New York, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
The University of Texas Health Science Center at San Antonio
🇺🇸
San Antonio, Texas, United States
Virginia Mason Medical Center
🇺🇸
Seattle, Washington, United States
Metro North Hospital and Health Services
🇦🇺
Brisbane, Australia
Cornell Medical Center
🇺🇸
New York, New York, United States
Institut Paoli-Calmettes
🇫🇷
Marseille, France
Dr. George Mukhari Academic Hospital
🇿🇦
Ga-Rankuwa, South Africa