Clinical trial NCT04103749: Global Prospective Case Series Using a Single-Use Duodenoscope
Official title: Global Prospective Case Series Using a Single-Use Duodenoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successful ERCP Procedure
timeFrame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
Secondary outcomes:
measure: Endoscopist Rating
timeFrame: Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.
measure: Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope
timeFrame: Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).
measure: Number of Adverse Events (SAEs) Related to the Device and/or the Procedure
timeFrame: SAEs are assessed through 30 days after the procedure.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles Medical Center
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indianapolis University Hospital
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Cornell Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Brisbane
country: Australia
facility: Metro North Hospital and Health Services
city: Toronto
country: Canada
facility: St. Michael's Hospital - Unity Health
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
state: North Rhine-Westphalia
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Telangana
city: Kolkata
country: India
facility: Apollo Multispeciality Hospitals
state: West Bengal
city: Milan
country: Italy
facility: Humanitas University
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center of Rotterdam
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Ga-Rankuwa
country: South Africa
facility: Dr. George Mukhari Academic Hospital
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Adam Slivka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Marco Bruno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: