Last reviewed · How we verify
NCT05829447: COMBAT
Combining Artificial Intelligence With Balloon Mucosal Exposure Device for Polyp Detection in Screening Individuals
NA trial testing G-EYE 760 R endoscope in Polyp of Colon in 686 participants. Completed in 1 December 2023.
1 December 2023
Quick facts
| Lead sponsor | Valduce Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 686 |
| Start date | 1 May 2023 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- G-EYE 760 R endoscope
Conditions studied
- Polyp of Colon — all drugs for Polyp of Colon →
Sponsor
Valduce Hospital
Who can join
Adults 50 to 74, any sex, with Polyp of Colon. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present trial is aimed at evaluating whether in individuals scheduled for colonoscopy in the framework of a structured FIT (Fecal Immunochemical stool test)-based colorectal cancer screening program, the combination of an AI (artificial intelligence) system (CADEYE) with a mucosal exposure device (G-EYE 760R endoscope) increases the identification of subjects at high risk to develop colorectal cancer (according to recent ESGE-European Society of Gastrointestinal Endoscopy guidelines subjects are labelled as "high-risk" if harboring at least 1 adenoma ≥ 10 mm or with high grade dysplasia, or ≥ 5 adenomas, or any serrated polyp ≥ 10 mm or with dysplasia) when compared to colonoscopy performed with the support of AI only. Individuals fulfilling inclusion criteria are randomized (1:1) to two different arms (Control arm and Interventional arm, see below). Randomization is based on a computer-generated randomized block sequence, stratified according to age (50-61 vs. 62-74) and gender (male vs. female); size of the blocks (10 individuals) is not communicated to the investigator. Allocation is concealed and kept in a sealed envelope, which is opened just before starting colonoscopy. Individuals randomized in the Intervention arm receive colonoscopy examination with G-EYE 760R colonoscopes; once the cecum is reached the balloon is inflated, and the endoscope is withdrawn with the inflated balloon; the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination. Individuals randomized in the Control arm (CADEYE only) receive colonoscopy with G-EYE 760R colonoscope but the balloon remains deflated for the entire procedure; the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination. The main outcome measure is the rate of "high risk" individuals across the two study arms.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05829447
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Polyp of Colon
Currently open trials in the same condition.
- NCT07007598 — Prevention of Post-Polypectomy Colorectal Bleeding by Clips in Patients on Anticoagulants · recruiting
- NCT06271941 — Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps · NA · recruiting
- NCT06447012 — Artificial Intelligence Development for Colorectal Polyp Diagnosis · recruiting
- NCT06822816 — Video/Image Library of Endoscopy Procedures for the Development of AI-empowered Endoscopy Quality Reporting and Educatio · recruiting
- NCT04117100 — Advanced Endo-therapeutic Procedure : Registry-based Observational Study · recruiting
Other Valduce Hospital trials
Trials by the same sponsor.
- NCT05492656 — Accuracy of CADx System for White Light Colonic Polyp Characterization · completed
- NCT04691401 — Impact of Artificial Intelligence (AI) on Adenoma Detection During Colonoscopy in FIT+ Patients. · NA · completed
- NCT04607083 — Impact of Computer-aided Optical Diagnosis (CAD) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicente · completed
- NCT04364412 — Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy · completed
- NCT03746171 — Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05829447 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Valduce Hospital
- Last refreshed: 26 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05829447.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing