Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

NCT ID: NCT03117114

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-06-06

Brief Summary

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.

Conditions

Colon Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Arm

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

Group Type: OTHER

Standard polypectomy

Intervention Type: OTHER

Absence of an EVD, standard polypectomy

Endocuff Vision Arm

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

Group Type: ACTIVE_COMPARATOR

Endocuff Vision assisted polypectomy

Intervention Type: DEVICE

EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy

Interventions

Endocuff Vision assisted polypectomy

EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy

Intervention Type: DEVICE

Standard polypectomy

Absence of an EVD, standard polypectomy

Intervention Type: OTHER

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Klare, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Locations

Klinikum rechts der Isar der TU München

Munich, Bavaria, Germany

Countries

Germany

References

von Figura G, Hasenohrl M, Haller B, Poszler A, Ulrich J, Brown H, Abdelhafez M, Schmid RM, von Delius S, Klare P. Endocuff vision-assisted vs. standard polyp resection in the colorectum (the EVASTA study): a prospective randomized study. Endoscopy. 2020 Jan;52(1):45-51. doi: 10.1055/a-1018-1870. Epub 2019 Oct 15.

Reference Type: DERIVED

PMID: 31614373 (View on PubMed)

Other Identifiers

EVASTA

Identifier Type: -

Identifier Source: org_study_id