Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-01-29
Brief Title:
The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration- Randomized Controlled Trial- A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
NOTSC-01
Brief Summary:
New endoscopic clipping device called the over-the-scope-clip OTSC system Ovesco Endoscopy Tübingen Germany has become available for the closure of perforations anastomotic leaks and fistulas The OTSC system has a stronger closing force than the through-the-scope hemostatic clip Therefore some researchers have reported esophageal SEMS fixation with an OTSC to prevent migration
Detailed Description:
Participants requiring esophageal SEMS placement for various indications such as stricture benign malignant leaks All participants who require esophageal SEMS placement Esophago-gastroscopy will be done to assess the feasibility of SEMS placement
Participants are randomized into two arms- one arm interventional use of OTSC stent fix after esophageal SEMS placement or the other arm non-interventional esophageal SEMS is placed
Participants are followed up for 1 year to observe stent migration rate in both the groups
Participants are randomized into two arms- one arm interventional use of OTSC stent fix after esophageal SEMS placement or the other arm non-interventional esophageal SEMS is placed
Participants are followed up for 1 year to observe stent migration rate in both the groups
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