Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXI (TXI group) | Experimental | Arm undergoing normal colonoscopy with TXI light |
|
| WLI (White Light Imaging Group) | Active Comparator | Arm undergoing normal colonoscopy with standard white light |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TXI Light Imaging | Diagnostic Test | Standard Colonoscopy using TXI imaging |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rate (ADR) | the proportion of participants with at least one adenoma (per-patient analysis) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Advanced ADR | 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 |
Not provided
Inclusion criteria:
- All >40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Dei Castelli | Ariccia | Rome | 00040 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37451283 | Derived | Antonelli G, Bevivino G, Pecere S, Ebigbo A, Cereatti F, Akizue N, Di Fonzo M, Coppola M, Barbaro F, Walter BM, Sharma P, Caruso A, Okimoto K, Antenucci C, Matsumura T, Zerboni G, Grossi C, Meinikheim M, Papparella LG, Correale L, Costamagna G, Repici A, Spada C, Messmann H, Hassan C, Iacopini F. Texture and color enhancement imaging versus high definition white-light endoscopy for detection of colorectal neoplasia: a randomized trial. Endoscopy. 2023 Dec;55(12):1072-1080. doi: 10.1055/a-2129-7254. Epub 2023 Jul 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| WLI Imaging |
| Diagnostic Test |
Standard Colonoscopy using White Light Imaging |
|
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 | the total number of detected lesions in each group divided by the total number of participants (per-polyp analysis) | 1 year |
| 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 |