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TXI for the Recognition of Adenomas in Colonoscopy (TRACK)

Primary Purpose

Colorectal Polyp

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TXI Light Imaging
WLI Imaging
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Polyp

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ospedale Dei Castelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TXI (TXI group)

WLI (White Light Imaging Group)

Arm Description

Arm undergoing normal colonoscopy with TXI light

Arm undergoing normal colonoscopy with standard white light

Outcomes

Primary Outcome Measures

Adenoma Detection Rate (ADR)
the proportion of participants with at least one adenoma (per-patient analysis)

Secondary Outcome Measures

Advanced ADR
as the proportion of participants with at least one advanced adenoma at a per-patient analysis
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)
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)
Withdrawal time
Time from the start of the inspection at the cecum and the withdrawal of the colonoscope from the body of the patient.

Full Information

First Posted
May 3, 2021
Last Updated
November 2, 2022
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT04892966
Brief Title
TXI for the Recognition of Adenomas in Colonoscopy
Acronym
TRACK
Official Title
Texture and Color Enhancement Imaging (TXI) Versus Standard White-light (WLI) Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
747 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TXI (TXI group)
Arm Type
Experimental
Arm Description
Arm undergoing normal colonoscopy with TXI light
Arm Title
WLI (White Light Imaging Group)
Arm Type
Active Comparator
Arm Description
Arm undergoing normal colonoscopy with standard white light
Intervention Type
Diagnostic Test
Intervention Name(s)
TXI Light Imaging
Intervention Description
Standard Colonoscopy using TXI imaging
Intervention Type
Diagnostic Test
Intervention Name(s)
WLI Imaging
Intervention Description
Standard Colonoscopy using White Light Imaging
Primary Outcome Measure Information:
Title
Adenoma Detection Rate (ADR)
Description
the proportion of participants with at least one adenoma (per-patient analysis)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Advanced ADR
Description
as the proportion of participants with at least one advanced adenoma at a per-patient analysis
Time Frame
1 year
Title
polyps, adenomas, advanced adenomas and Sessile Serrated Polyps (SSP) per subject
Description
the total number of detected lesions in each group divided by the total number of participants (per polyp analysis)
Time Frame
1 year
Title
proximal and flat adenomas detection rate
Description
the total number of detected lesions in each group divided by the total number of participants (per-polyp analysis)
Time Frame
1 year
Title
Withdrawal time
Description
Time from the start of the inspection at the cecum and the withdrawal of the colonoscope from the body of the patient.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ospedale Dei Castelli
City
Ariccia
State/Province
Rome
ZIP/Postal Code
00040
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

TXI for the Recognition of Adenomas in Colonoscopy

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