Initial Case Series With Exalt Single-Use Duodenoscope

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03701958

Collaborator

(none)

Enrollment

Locations

Arm

1.7

Actual Duration (Months)

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography	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. 35-70 cases will be included at up to 10 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 7 days after their procedure.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Initial Case Series With Exalt Single-Use Duodenoscope

Actual Study Start Date :

Apr 15, 2019

Actual Primary Completion Date :

May 6, 2019

Actual Study Completion Date :

Jun 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Exalt DScope 01 Subjects will have a clinically indicated per standard of care ERCP 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 procedure performed with the Exalt single use duodenoscope study device.

Arm

Intervention/Treatment

Other: Exalt DScope 01

Subjects will have a clinically indicated per standard of care ERCP 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 procedure performed with the Exalt single use duodenoscope study device.

Outcome Measures

Primary Outcome Measures

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

Endoscopist qualitative rating [Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure (within 24 hours 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.
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.
Evaluation of adverse events (SAEs) related to the device and/or the procedure [SAEs are assessed through 7 days after the procedure.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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	Ronald Reagan 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	55905
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

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator: V. Raman Muthusamy, MD, University of California, Los Angeles
Principal Investigator: Andrew Ross, MD, Virginia Mason Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT03701958

Other Study ID Numbers:

E7145

First Posted:

Oct 10, 2018

Last Update Posted:

Feb 8, 2022

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 8, 2022