Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy

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

COMPLETED

Clinical Phase

NA

Total Enrollment

1160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-30

Study Completion Date

2023-04-30

Brief Summary

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The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.

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Detailed Description

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Conditions

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Adenoma Colon Colonic Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CADe Colonoscopy

Colonoscopy with the help of CADe system (ENDO-Aid)

Group Type EXPERIMENTAL

ENDO-Aid by Olympus

Intervention Type DEVICE

Colonoscopy assisted by ENDO-AID device

Conventional Colonoscopy

Standard Colonoscopy with white light

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ENDO-Aid by Olympus

Colonoscopy assisted by ENDO-AID device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years or ≤85
* Patients undergoing screening, follow-up, or diagnostic colonoscopy

Exclusion Criteria

* Suspected or known inflammatory bowel disease
* Colonic resection
* Taking anticoagulants or antiaggregants that contraindicate the performance of therapy
* Patients with incomplete colonoscopy
* Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
* Inability to provide informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No