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Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm
The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.
The details of the proposed study are as follows: 1. Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon 2. Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon 3. Methods: 1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place. 2. If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift. 3. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion. 4. The polyp as well as well as the two biopsies are reviewed by a pathologist.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States
Start Date
September 16, 2020
Primary Completion Date
May 31, 2021
Completion Date
July 15, 2021
Last Updated
September 1, 2022
158
ACTUAL participants
Use of EverLift
DEVICE
Without use of EverLift
DEVICE
Lead Sponsor
Stanford University
Data Source & Attribution
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