Global Prospective Case Series Using a Single-Use Duodenoscope

NCT04103749 | Completed Results FDA Device

• 1 other identifier: E7156
• Study Type: interventional
• Target: 551
• Locations: 11 countries
• Sites: 22

Brief Summary

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

Conditions

Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful ERCP Procedure

  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.

  Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).

Secondary Outcomes (3)

• 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.

• 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).

• Number of Adverse Events (SAEs) Related to the Device and/or the Procedure

  SAEs are assessed through 30 days after the procedure.

Study Arms (1)

Exalt DScope 02

EXPERIMENTAL

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

Interventions

Exalt Model D Single-Use Duodenoscope DEVICE

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.

Exalt DScope 02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (22)

University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indianapolis University Hospital

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Cornell Medical Center

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Metro North Hospital and Health Services

Brisbane, Australia

Location

St. Michael's Hospital - Unity Health

Toronto, M5B 1W8, Canada

Location

Institut Paoli-Calmettes

Marseille, France

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Asian Institute of Gastroenterology

Hyderabad, Telangana, India

Location

Apollo Multispeciality Hospitals

Kolkata, West Bengal, 700054, India

Location

Humanitas University

Milan, Italy

Location

Erasmus University Medical Center of Rotterdam

Rotterdam, 3015 CN, Netherlands

Location

Singapore General Hospital

Singapore, Singapore

Location

Dr. George Mukhari Academic Hospital

Ga-Rankuwa, South Africa

Location

Related Publications (1)

• Bruno MJ, Beyna T, Carr-Locke D, Chahal P, Costamagna G, Devereaux B, Giovannini M, Goenka MK, Khor C, Lau J, May G, Muthusamy VR, Patel S, Petersen BT, Pleskow DK, Raijman I, Reddy DN, Repici A, Ross AS, Sejpal DV, Sherman S, Siddiqui UD, Ziady C, Peetermans JA, Rousseau MJ, Slivka A; EXALT Single-use Duodenoscope Study Group. Global prospective case series of ERCPs using a single-use duodenoscope. Endoscopy. 2023 Dec;55(12):1103-1114. doi: 10.1055/a-2131-7180. Epub 2023 Jul 18.

  PMID: 37463599 DERIVED

Limitations and Caveats

Limitations include the lack of randomization and the absence of a control group. The enrolled subjects may not be typical of patients at all endoscopy centers. Several investigators participated in the development of the single-use duodenoscope and also received research funding from the study sponsor and from manufacturers of reusable duodenoscopes. Lastly, this study did not address the associated costs or impact on reprocessing services or the environment.

Results Point of Contact

• Title: Victoria Lazzari
• Organization: Boston Scientific Corporation

victoria.lazzari@bsci.com

508-382-9132

Study Officials

• Adam Slivka, MD, PhD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

• Marco Bruno, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 25, 2019
• Study Start: March 22, 2021
• Primary Completion: November 23, 2022
• Study Completion: January 5, 2023
• Last Updated: December 12, 2023
• Results First Posted: December 12, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); IN (2); IT (1); US (11); DE (1); CA (1); HK (1); AU (1); SG (1); ZA (1); NL (1)