TXI for the Recognition of Adenomas in Colonoscopy

Colorectal Polyp Clinical Trial

— TRACK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892966
• Other study ID #: TRACK_GA
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 747
• Est. completion date: September 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Polyp

Intervention

Diagnostic Test:
• TXI Light Imaging
Standard Colonoscopy using TXI imaging
• WLI Imaging
Standard Colonoscopy using White Light Imaging

Locations

Country	Name	City	State
Italy	Ospedale Dei Castelli	Ariccia	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

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