Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03654209
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2018-08-23
Brief Title:
Post-resection Treatment of Large Colon Polyps
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation or Argon Plasma Coagulation
Status:
COMPLETED
Status Verified Date:
2024-01
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:
SAP
Brief Summary:
Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection EMR of lesions 15mm and larger will be randomized to STSC 80 W Effect 5 vs APC preferred settings vs No Treatment of the perimeter of the EMR site
Detailed Description:
Data regarding polyp morphology location shape will be recorded in addition to procedure and treatment length Injection fluid use and clipping will also be recorded in addition to any procedural complications
All randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled as per the standard of care to receive a standard follow-up colonoscopy procedure after the initial procedure The investigators will measure the rate of recurrence by endoscopic visualization of the EMR site at the first follow-up using endoscopic magnification and electronic chromoendoscopy as well as systematic biopsy of the scars
All randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled as per the standard of care to receive a standard follow-up colonoscopy procedure after the initial procedure The investigators will measure the rate of recurrence by endoscopic visualization of the EMR site at the first follow-up using endoscopic magnification and electronic chromoendoscopy as well as systematic biopsy of the scars
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None