Enchasing Polyp Detection: The Effect of Adding Polyp Detection Attachment Device to Computer Aid Detection System.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1766 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2025-04-15

Brief Summary

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Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.

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Detailed Description

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Conditions

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Colon Cancer Screening Colon Cancer Surveillance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial that compares Endocuff with Gi Genius (group A) to GI Genius alone (group B) for patients who are undergoing elective outpatient colonoscopy. Patients will be randomized by a secure online randomization software that will allocate patients in a 1:1 ratio to group A or group B.

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Endocuff + GI Genius

Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Group Type EXPERIMENTAL

Endocuff and GI Genius

Intervention Type DEVICE

Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

GI Genius

GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Group Type ACTIVE_COMPARATOR

GI Genius

Intervention Type DEVICE

GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Interventions

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Endocuff and GI Genius

Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Intervention Type DEVICE

GI Genius

GI Genius is and Computer-Aid Detection (CADe) system to detect polyps

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Patients scheduled for an outpatient screening or surveillance colonoscopy.

Exclusion Criteria

* Patients who require diagnostic colonoscopy (e.g.; anemia or GI bleeding).
* Patients requiring deep ileal intubation.
* Patients with inflammatory bowel disease.
* Patients with radiotherapy-induced colitis or other severe colitis.
* Patients with colonic strictures.
* Patients with acute diverticulitis.
* Patients with large bowel obstruction.
* Patients scheduled for therapeutic colonoscopy (e.g., planned endoscopic mucosal resection for known polyps).
* Patients scheduled for assessment of a known colonic lesion.
* Patients with a known history of hereditary polyposis syndrome or untreated colon cancer.
* Patients with a history of colon resection.
* Patients on continuous anti-thrombotic therapy
* Pregnancy.
* Patients who are ineligible for colonoscopy due to medical or psychiatric conditions.
* Patients who are vulnerable or unable to consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes