TXI for the Recognition of Adenomas in 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

747 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-09-30

Brief Summary

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This two parallel arms, randomized, multicenter trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of adenoma detection. Secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time.

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Detailed Description

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Conditions

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Colorectal Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TXI (TXI group)

Arm undergoing normal colonoscopy with TXI light

Group Type EXPERIMENTAL

TXI Light Imaging

Intervention Type DIAGNOSTIC_TEST

Standard Colonoscopy using TXI imaging

WLI (White Light Imaging Group)

Arm undergoing normal colonoscopy with standard white light

Group Type ACTIVE_COMPARATOR

WLI Imaging

Intervention Type DIAGNOSTIC_TEST

Standard Colonoscopy using White Light Imaging

Interventions

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TXI Light Imaging

Standard Colonoscopy using TXI imaging

Intervention Type DIAGNOSTIC_TEST

WLI Imaging

Standard Colonoscopy using White Light Imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- All \>40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance

Exclusion Criteria

* patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD).
* Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes