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

Stanford University

Status: Completed

Conditions: Adenomatous Polyp of Colon; Colo-rectal Cancer; Polyp of Colon

Treatments: Device: Without use of EverLift; Device: Use of EverLift

Study type: Interventional

Funder types: Other

Identifiers

NCT04551014

15766-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnant
• Inflammatory bowel disease
• Polyposis syndromes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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158 participants in 2 patient groups

With EverLift

Experimental group

Description:

Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.

Treatment:

Device: Use of EverLift

Without EverLift

Experimental group

Description:

Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.

Treatment:

Device: Without use of EverLift