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

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.

Study Overview

• Status: Completed
• Conditions: Colon Polyp
• Intervention / Treatment: Other: Standard polypectomy; Device: Endocuff Vision assisted polypectomy

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81657
      • Klinikum Rechts der Isar der TU München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard Arm; Standard colonoscopy without mounted Endocuff Vision device. Therefore standard polypectomy in case of polyp resection.	Other: Standard polypectomy; Absence of an EVD, standard polypectomy
Active Comparator: 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.	Device: Endocuff Vision assisted polypectomy; EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp detection	a maximum of one day is expected for colonoscopy procedures	up to day 1
Cecal intubation time	Time span until cecum is reached with the tip of the scope	up to day 1
Ileum intubation time	Time span until ileum is reached	up to day 1
Total procedure duration	Total procedure duration	up to day 1
Complications	Bleeding, perforation and other complications	up to day 1
Propofol dosage	Amount of propofol used for colonoscopy	up to day 1
Patient satisfaction	Measured on a 10 point numeric scale	up to day 1

Collaborators and Investigators

• Sponsor: Technical University of Munich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: April 8, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: colonoscopy; resection; polyp
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: EVASTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No