Clinical trial NCT03701958: Initial Case Series With Exalt Single-Use Duodenoscope
Official title: Initial Case Series With Exalt 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: 2018-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

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:

* 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: 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 qualitative rating
timeFrame: 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).
measure: Incidence of 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: Evaluation of 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: Ronald Reagan 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
Study officials:
affiliation: University of California, Los Angeles
name: V. Raman Muthusamy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Mason Medical Center
name: Andrew Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2108-2117.e3. doi: 10.1016/j.cgh.2019.10.052. Epub 2019 Nov 6.