Status:
WITHDRAWN
Exalt D Single-use Duodenoscope in ERCP Procedures in China
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Cholangiopancreatography
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study Objective(s)：This study is to evaluate the feasibility, preliminary safety and performance of Exalt D Single-use Duodenoscope in ERCP procedures in China, to generate local real world data from ...
Detailed Description
Device Description：The Exalt™ Model D Single-Use Duodenoscope is a sterile, single-use endoscope that facilitates access to the duodenum, delivery of accessories, and live video when connected to an E...
Eligibility Criteria
Inclusion
- 18 years or older
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Schedule for a clinically indicated ERCP
Exclusion
- Potentially vulnerable subjects, including, but not limited to pregnant women
- Subjects for whom endoscopic techniques are contraindicated
- Subjects 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04687774
Start Date
August 1 2022
End Date
October 1 2022
Last Update
November 17 2025
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