Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03219619
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2017-07-13
Brief Title:
Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla
Sponsor:
Air Force Military Medical University China
Organization:
Air Force Military Medical University China
Study Overview
Official Title:
Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla a Randomized Non-inferiority Trial
Status:
COMPLETED
Status Verified Date:
2019-10
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:
Examination of major duodenal papilla MDP using a side-viewing duodenoscope is a golden standard However side-viewing duodenoscope is not available in some endoscopic centers Cap-assisted esophagogastroduodenoscopy Ca-EGD using a transparent cap fitted to the tip of the scope has emerged as an alternative method for the observation of MDP A recent study showed that complete examination of MDP could be achieved in 97 of patients The investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of MDP
Detailed Description:
Interim analyses were planned to be performed by the data and safety monitoring board after data collection has been completed for 50 of the enrollment
Study Oversight
Has Oversight DMC:
None
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?:
None