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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04103749




Registration number
NCT04103749
Ethics application status
Date submitted
20/09/2019
Date registered
25/09/2019
Date last updated
12/12/2023

Titles & IDs
Public title
Global Prospective Case Series Using a Single-Use Duodenoscope
Scientific title
Global Prospective Case Series Using a Single-Use Duodenoscope
Secondary ID [1] 0 0
E7156
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endoscopic Retrograde Cholangiopancreatography 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Exalt Model D Single-Use Duodenoscope

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.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Successful ERCP Procedure
Timepoint [1] 0 0
Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
Secondary outcome [1] 0 0
Endoscopist Rating
Timepoint [1] 0 0
Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.
Secondary outcome [2] 0 0
Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope
Timepoint [2] 0 0
Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).
Secondary outcome [3] 0 0
Number of Adverse Events (SAEs) Related to the Device and/or the Procedure
Timepoint [3] 0 0
SAEs are assessed through 30 days after the procedure.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/01/2023
Sample size
Target
Accrual to date
Final
551
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Metro North Hospital and Health Services - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Canada
State/province [11] 0 0
Toronto
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
Germany
State/province [13] 0 0
North Rhine-Westphalia
Country [14] 0 0
Hong Kong
State/province [14] 0 0
Hong Kong
Country [15] 0 0
India
State/province [15] 0 0
Telangana
Country [16] 0 0
India
State/province [16] 0 0
West Bengal
Country [17] 0 0
Italy
State/province [17] 0 0
Milan
Country [18] 0 0
Netherlands
State/province [18] 0 0
Rotterdam
Country [19] 0 0
Singapore
State/province [19] 0 0
Singapore
Country [20] 0 0
South Africa
State/province [20] 0 0
Ga-Rankuwa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic
Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures
Trial website
https://clinicaltrials.gov/ct2/show/NCT04103749
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adam Slivka, MD, PhD
Address 0 0
University of Pittsburgh Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries