NCT03117114: EVASTA

Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

Completed NA Last updated 11 June 2019

What this trial tests

NA trial testing Endocuff Vision assisted polypectomy in Colon Polyp in 250 participants. Completed in 6 June 2019.

Timeline

1 June 2017

Primary endpoint
1 September 2018

6 June 2019

Quick facts

Lead sponsor	Technical University of Munich
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	250
Start date	1 June 2017
Primary completion	1 September 2018
Estimated completion	6 June 2019
Sites	1 location across Germany

Drugs / interventions tested

• Endocuff Vision assisted polypectomy
• Standard polypectomy

Conditions studied

• Colon Polyp — all drugs for Colon Polyp →

Sponsor

Technical University of Munich

Who can join

Adults 18 to 95, any sex, with Colon Polyp. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Adenomas are premalignant polyps of the colon that should be resected endoscopically. Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be conducted using the so-called piece meal technique in these cases. However, leaving polyp residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer may arise form adenomatous remnants. In case of difficult polyp locations endoscopic resection may also be time consuming. On the other hand endoscopists are facing an increased time pressure due to rising numbers of procedures during the last decades.

The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard endoscope. The EVD has small flexible branches on its outside. The branches turn out during withdrawal. By that the branches are getting in contact with colonic wall. This mechanism leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that resection circumstances may be improved by using an EVD. In addition, stabilizing the scope during resection may result in a reduced time effort. Until now no controlled trials exist investigating the effect of EVD on the time effect during polyp resection. Therefore a randomized controlled trial needed comparing standard polypectomy versus polypectomy using the EVD during routine colonoscopy procedures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.