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OpenTrials
Completed

NCT Number: NCT03117114

Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum rechts der Isar der TU München

Munich, Bavaria, 81657, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Endocuff Vision assisted polypectomy

Device

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

Standard polypectomy

Other

Absence of an EVD, standard polypectomy

Primary outcomes

  1. Polyp resection

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

    Time of polyp resection will be measured using a stopwatch.

Secondary outcomes

  1. Polyp detection

    Time frame: up to day 1

    a maximum of one day is expected for colonoscopy procedures

  2. Cecal intubation time

    Time frame: up to day 1

    Time span until cecum is reached with the tip of the scope

  3. Ileum intubation time

    Time frame: up to day 1

    Time span until ileum is reached

  4. Total procedure duration

    Time frame: up to day 1

    Total procedure duration

  5. Complications

    Time frame: up to day 1

    Bleeding, perforation and other complications

  6. Propofol dosage

    Time frame: up to day 1

    Amount of propofol used for colonoscopy

  7. Patient satisfaction

    Time frame: up to day 1

    Measured on a 10 point numeric scale

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Acronym: EVASTA

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 17, 2017
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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