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

Study Overview
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Brief Summary
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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
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The details of the proposed study are as follows: Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon Methods: Colonoscopy will be performed in the same standard of care manner as if no study was taking place. If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion. The polyp as well as well as the two biopsies are reviewed by a pathologist.

Official Title
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Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm

Conditions
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Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyp of Colon

Intervention / Treatment
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* Device: Use of EverLift
* Device: Without use of EverLift


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years or older Polyps 4-9mm Exclusion Criteria: Pregnant Inflammatory bowel disease Polyposis syndromes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With EverLift<br>Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift. | Device: Use of EverLift<br>* Use of EverLift for submucosal injection prior to polypectomy<br>|
| Experimental: Without EverLift<br>Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift. | Device: Without use of EverLift<br>* Without use of EverLift for submucosal injection prior to polypectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Polyps With Complete Resection | The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Resection | The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups. | During the procedure | 
| 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 | 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. | 4 weeks (from procedure through 30 day follow-up) |