Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756453
Status:
RECRUITING
Last Update Posted:
2023-03-08
First Post:
2021-02-11
Brief Title:
The Effect of Clip-traction on ESD Resection Time
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
The Effect of Clip-traction on ESD Resection Time A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Patients scheduled for an endoscopic submucosal dissectionESD in the colorectum will be randomized to the use of a traction deviceconsisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed another clip will anchor the loop to adjacent bowel wall or a standard ESD
Detailed Description:
Patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard ESD Location morphology and size of the lesion will be recorded Time of the procedure will be measured using a stopwatch
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