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

Stanford University158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

158

Conditions

Colo-rectal Cancer Polyp of Colon Adenomatous Polyp of Colon

Interventions

Use of EverLiftDEVICE

Use of EverLift for submucosal injection prior to polypectomy

Without use of EverLiftDEVICE

Without use of EverLift for submucosal injection prior to polypectomy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, United States

Outcomes

Primary Outcomes

Number of Polyps With Complete Resection

The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.

Time frame: 2 weeks

Secondary Outcomes

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.

Time frame: During the procedure

Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.

Time frame: 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.

Time frame: 4 weeks (from procedure through 30 day follow-up)

Data from ClinicalTrials.gov

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