TXI for the Recognition of Adenomas in Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Polyp
• Interventions: Diagnostic Test: WLI Imaging; Diagnostic Test: TXI Light Imaging

• Registration Number: NCT04892966
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-19
• Primary Completion: 2022-04-30
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 747

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WLI (White Light Imaging Group)	WLI Imaging	Arm undergoing normal colonoscopy with standard white light
TXI (TXI group)	TXI Light Imaging	Arm undergoing normal colonoscopy with TXI light

Primary Outcome Measures

Name	Time	Method
Adenoma Detection Rate (ADR)	1 year	the proportion of participants with at least one adenoma (per-patient analysis)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ospedale Dei Castelli; 🇮🇹 Ariccia, Rome, Italy