Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

NCT03117114 | Completed

• 1 other identifier: EVASTA
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

colonoscopy; polyp; resection

Outcome Measures

Primary Outcomes (1)

• Polyp resection

  Time of polyp resection will be measured using a stopwatch.

  up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)]

Secondary Outcomes (7)

• Polyp detection

  up to day 1

• Cecal intubation time

  up to day 1

• Ileum intubation time

  up to day 1

• Total procedure duration

  up to day 1

• Complications

  up to day 1

Study Arms (2)

Standard Arm

OTHER

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

Other: Standard polypectomy

Endocuff Vision Arm

ACTIVE COMPARATOR

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

Device: Endocuff Vision assisted polypectomy

Interventions

Endocuff Vision assisted polypectomy DEVICE

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

Endocuff Vision Arm

Standard polypectomy OTHER

Absence of an EVD, standard polypectomy

Standard Arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication for colonoscopy
• age ≥ 40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar der TU München

Munich, Bavaria, 81657, Germany

Location

Related Publications (1)

• 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.

  PMID: 31614373 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Klare, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2017
• First Posted: April 17, 2017
• Study Start: June 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: June 6, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)