---
title: Effectiveness of Endocuff Vision in Improving ADR
nct_id: NCT04395352
overall_status: COMPLETED
sponsor: University of Calgary
study_type: OBSERVATIONAL
primary_condition: Colorectal Neoplasms
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04395352.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04395352"
ct_last_update_post_date: 2020-05-20
last_seen_at: "2026-05-12T06:42:46.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effectiveness of Endocuff Vision in Improving ADR

**Official Title:** Effectiveness of EndoCuff Vision in Improving Adenoma Detection Rate in a Large Screening-Related Cohort

**NCT ID:** [NCT04395352](https://clinicaltrials.gov/study/NCT04395352)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 15816
- **Lead Sponsor:** University of Calgary
- **Conditions:** Colorectal Neoplasms
- **Start Date:** 2018-11-01
- **Completion Date:** 2019-11-30
- **CT.gov Last Update:** 2020-05-20

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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).

## Interventions

- **Endocuff Vision (ECV)** (DEVICE) — Detachable disposable (single-use) device that fits over the distal colonoscope end.

## Primary Outcomes

- **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

- **Adenoma detection rate among patients with positive fecal immunochemical tests** _(time frame: Intra-procedural)_
- **SSADR (sessile serrated adenoma detection rate)** _(time frame: Intra-procedural)_
- **CIR (cecal intubation rate)** _(time frame: Intra-procedural)_
- **Procedure time** _(time frame: Intra-procedural)_
- **Nurse-assessed patient comfort scores (NAPCOMs)** _(time frame: Intra-procedural)_
- **Number of patients with immediate adverse events** _(time frame: Day 1)_
- **Number of patients with delayed adverse events** _(time frame: Within 30 days of index procedure)_

## Locations (1)

- Forzani and MacPhail Colon Cancer Screening Centre (CCSC), Calgary, Alberta, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.forzani and macphail colon cancer screening centre (ccsc)|calgary|alberta|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04395352.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04395352*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*