Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-21 @ 2:32 PM
Study NCT ID:
NCT03701958
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2018-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Case Series With Exalt Single-Use Duodenoscope
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Initial Case Series With Exalt Single-Use Duodenoscope
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: