Effectiveness of Endocuff Vision in Improving ADR

NCT04395352 | Completed FDA Device

• 1 other identifier: HREBA.CC-19-0257
• Study Type: observational
• Target: 15,816
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate (ADR)

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

  Intra-procedural

Secondary Outcomes (7)

• Adenoma detection rate among patients with positive fecal immunochemical tests

  Intra-procedural

• SSADR (sessile serrated adenoma detection rate)

  Intra-procedural

• CIR (cecal intubation rate)

  Intra-procedural

• Procedure time

  Intra-procedural

• Nurse-assessed patient comfort scores (NAPCOMs)

  Intra-procedural

Study Arms (2)

Pre-ECV

Patients having undergone colonoscopy prior to the introduction of ECV (November 1 2018 to April 30 2019).

ECV

Patients having undergone colonoscopy after the introduction of ECV (June 1 2019 to November 30 2019).

Device: Endocuff Vision (ECV)

Interventions

Endocuff Vision (ECV) DEVICE

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

ECV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing screening-related colonoscopy.

You may qualify if:

• adult patients undergoing colonoscopy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Forzani and MacPhail Colon Cancer Screening Centre (CCSC)

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 20, 2020
• Study Start: November 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)