Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Number of Polyps With Complete Resection
Study Overview
Brief Summary
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.
Detailed Description
The details of the proposed study are as follows:
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Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon
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Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon
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Methods:
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Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
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If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift.
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After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
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The polyp as well as well as the two biopsies are reviewed by a pathologist.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients 18 years or older
- •Polyps 4-9mm
Exclusion Criteria
- •Inflammatory bowel disease
- •Polyposis syndromes
Arms & Interventions
With EverLift
Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.
Intervention: Use of EverLift (Device)
Without EverLift
Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
Intervention: Without use of EverLift (Device)
Outcomes
Primary Outcomes
Number of Polyps With Complete Resection
Time Frame: 2 weeks
The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.
Secondary Outcomes
- Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.(During the procedure (up to 10 minutes))
- Number of Patients With Procedural Complications(4 weeks (from procedure through 30 day follow-up))
- Time to Resection(During the procedure)
Investigators
Shai Friedland
Professor in Gastroenterology & Hepatology
Stanford University