Clinical trial NCT04223830: Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience
Official title: Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-01-10
Enrollment: 200
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: The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.

Detailed description: The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.

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 endoscopic retrograde cholangiopancreatography (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

Primary outcomes:
measure: Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
timeFrame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
Secondary outcomes:
measure: Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope
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 Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope
timeFrame: Crossover is monitored throughout the procedure (within 24 hours on study day 1).
measure: Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure
timeFrame: SAEs are assessed through 7 days after the procedure.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles Medical Center
state: California
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: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Adam Slivka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slivka A, Ross AS, Sejpal DV, Petersen BT, Bruno MJ, Pleskow DK, Muthusamy VR, Chennat JS, Krishnamoorthi R, Lee C, Martin JA, Poley JW, Cohen JM, Thaker AM, Peetermans JA, Rousseau MJ, Tirrell GP, Kozarek RA; EXALT Single-use Duodenoscope Study Group. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021 Dec;94(6):1046-1055. doi: 10.1016/j.gie.2021.06.017. Epub 2021 Jun 26.