TXI for the Recognition of Adenomas in Colonoscopy (TRACK)

November 2, 2022 updated by: Giulio Antonelli, University of Roma La Sapienza

Texture and Color Enhancement Imaging (TXI) Versus Standard White-light (WLI) Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

747

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rome
      • Ariccia, Rome, Italy, 00040
        • Ospedale dei Castelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TXI (TXI group)
Arm undergoing normal colonoscopy with TXI light
Diagnostic test: TXI Light Imaging
Standard Colonoscopy using TXI imaging
ACTIVE_COMPARATOR: WLI (White Light Imaging Group)
Arm undergoing normal colonoscopy with standard white light
Diagnostic test: WLI Imaging
Standard Colonoscopy using White Light Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma Detection Rate (ADR)
Time Frame: 1 year
the proportion of participants with at least one adenoma (per-patient analysis)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advanced ADR
Time Frame: 1 year
as the proportion of participants with at least one advanced adenoma at a per-patient analysis
1 year
polyps, adenomas, advanced adenomas and Sessile Serrated Polyps (SSP) per subject
Time Frame: 1 year
the total number of detected lesions in each group divided by the total number of participants (per polyp analysis)
1 year
proximal and flat adenomas detection rate
Time Frame: 1 year
the total number of detected lesions in each group divided by the total number of participants (per-polyp analysis)
1 year
Withdrawal time
Time Frame: 1 year
Time from the start of the inspection at the cecum and the withdrawal of the colonoscope from the body of the patient.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

April 30, 2022

Study Completion (ACTUAL)

September 30, 2022

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (ACTUAL)

May 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRACK_GA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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