Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum (EVASTA)

Technical University of Munich

Status: Completed

Conditions: Colon Polyp

Treatments: Other: Standard polypectomy; Device: Endocuff Vision assisted polypectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03117114

EVASTA

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• indication for colonoscopy
• age ≥ 40 years

Exclusion criteria

• American Society of Anesthesiologists class IV or higher
• pregnant women
• indication for colonoscopy: inflammatory bowel disease
• indication for colonoscopy: polyposis syndrome
• indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
• contraindication for polyp resection e.g. patients on warfarin

Exclusion Criteria:

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Standard Arm

Other group

Description:

Standard colonoscopy without mounted Endocuff Vision device. Therefore standard polypectomy in case of polyp resection.

Treatment:

Other: Standard polypectomy

Endocuff Vision Arm

Active Comparator group

Description:

Endocuff Vision device mounted to the endoscope prior to the beginning of the procedure. Therefore EVD assisted polypectomy in case of polyp resection.

Treatment:

Device: Endocuff Vision assisted polypectomy