Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm

Not Applicable

Completed

• Conditions: Polyp of Colon; Colo-rectal Cancer; Adenomatous Polyp of Colon
• Interventions: Device: Use of EverLift; Device: Without use of EverLift

• Registration Number: NCT04551014
• Lead Sponsor: Stanford University

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:

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.

Study Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Study Start: 2020-09-16
• Study First Posted: 2020-09-16
• Primary Completion: 2021-05-31
• Study Completion: 2021-07-15
• Results First Submitted: 2022-06-28
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-12
• Last Update Submitted: 2022-08-12
• Results First Posted: 2022-09-01
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Patients 18 years or older
• Polyps 4-9mm

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Exclusion Criteria

• Pregnant
• Inflammatory bowel disease
• Polyposis syndromes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With EverLift	Use of EverLift	Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.
Without EverLift	Without use of EverLift	Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.

Primary Outcome Measures

Name	Time	Method
Number of Polyps With Complete Resection	2 weeks	The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.

Secondary Outcome Measures

Name	Time	Method
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)	Procedural complications include perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality.
Time to Resection	During the procedure	The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups.

Trial Locations

Locations (1)

Veterans Affairs Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States