NCT04551014

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colo-rectal Cancer
• Polyp of Colon
• Adenomatous Polyp of Colon

Interventions

Type	Name	Description
DEVICE	Use of EverLift	Use of EverLift for submucosal injection prior to polypectomy
DEVICE	Without use of EverLift	Without use of EverLift for submucosal injection prior to polypectomy

Timeline

• Start date: 2020-09-16
• Primary completion: 2021-05-31
• Completion: 2021-07-15
• First posted: 2020-09-16
• Last updated: 2022-09-01
• Results posted: 2022-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study