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

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.

Study Overview

• Status: Completed
• Conditions: Polyp of Colon; Colo-rectal Cancer; Adenomatous Polyp of Colon
• Intervention / Treatment: Device: Use of EverLift; Device: Without use of EverLift

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 Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Veterans Affairs Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant
• Inflammatory bowel disease
• Polyposis syndromes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Shai Friedland, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Intestinal Polyps; Adenoma; Polyps; Colonic Polyps; Adenomatous Polyps
• Other Study ID Numbers: 15766-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes