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OpenTrials
Completed

NCT Number: NCT04892966

TXI for the Recognition of Adenomas in Colonoscopy

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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Key information

Conditions

Colorectal Polyp

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Dei Castelli

Ariccia, Rome, 00040, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TXI Light Imaging

Diagnostic Test

Standard Colonoscopy using TXI imaging

WLI Imaging

Diagnostic Test

Standard Colonoscopy using White Light Imaging

Primary outcomes

  1. Adenoma Detection Rate (ADR)

    Time frame: 1 year

    the proportion of participants with at least one adenoma (per-patient analysis)

Secondary outcomes

  1. Advanced ADR

    Time frame: 1 year

    as the proportion of participants with at least one advanced adenoma at a per-patient analysis

  2. 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)

  3. 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)

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: TRACK

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 19, 2021
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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