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OpenTrials
Completed

NCT Number: NCT04395352

Effectiveness of Endocuff Vision in Improving ADR

The goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. ECV has been shown to be efficacious in improving ADR within the context of randomized trials. However, no 'real-world' studies have been published assessing the effectiveness of ECV in non-trial settings. The primary objective of this study is to assess the effect of ECV use on ADR in a routine screening-related population.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Forzani and MacPhail Colon Cancer Screening Centre (CCSC)

Calgary, Alberta, T2N 4Z6, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

adult patients undergoing colonoscopy.

Exclusion criteria

  • single balloon- or double balloon-assisted colonoscopy;
  • planned advanced polypectomy or endoscopic mucosal resection (EMR);
  • planned endoscopic post-polypectomy or post-EMR surveillance;
  • known active diverticulitis;
  • known colonic stricture.

Treatment and study plan

Endocuff Vision (ECV)

Device

Detachable disposable (single-use) device that fits over the distal colonoscope end.

Primary outcomes

  1. Adenoma detection rate (ADR)

    Time frame: Intra-procedural

    Proportion of an endoscopist's screening-related colonoscopies during which one or more adenoma was biopsied or removed

Secondary outcomes

  1. Adenoma detection rate among patients with positive fecal immunochemical tests

    Time frame: Intra-procedural

    Proportion of an endoscopist's colonoscopies performed for +fecal immunochemical test (FIT), or indications other than positive FIT during which one or more adenoma was biopsied or removed. In order to be included in the non-FIT ADR category, a patient must not have undergone a colonoscopy at CCSC within the last four years of the index procedure.

  2. SSADR (sessile serrated adenoma detection rate)

    Time frame: Intra-procedural

    Proportion of an endoscopist's screening-related colonoscopies during which one or more sessile serrated adenoma was biopsied or removed

  3. CIR (cecal intubation rate)

    Time frame: Intra-procedural

    Proportion of an endoscopist's screening-related procedures in which the cecal pole is intubated, as landmarked by direct visualization of the appendiceal orifice, ileocecal valve, or both.

  4. Procedure time

    Time frame: Intra-procedural

    Total time spent by an endoscopist from the start of the colonoscopy procedure (insertion of the colonoscope through the anus) to the end of the colonoscopy (removal of the colonoscope from the anus). This variable will be calculated only for cases in which no pathology was encountered.

  5. Nurse-assessed patient comfort scores (NAPCOMs)

    Time frame: Intra-procedural

    Validated score for determining patients' procedural comfort. Scored from 0 to 9, with higher scores indicating higher discomfort intensity, frequency, and/or duration.

  6. Number of patients with immediate adverse events

    Time frame: Day 1

    Adverse events occurring at the time of colonoscopy or before discharge, including bleeding or perforation.

  7. Number of patients with delayed adverse events

    Time frame: Within 30 days of index procedure

    Adverse events within 30 days of the index procedure, including delayed bleeding, delayed perforation, or acute healthcare utilization (emergency department visit or hospital admission) for any other reasons deemed related to index colonoscopy.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Effectiveness of EndoCuff Vision in Improving Adenoma Detection Rate in a Large Screening-Related Cohort

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 20, 2020
Registry last updated
May 20, 2020

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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