Clinical trial · Interventional
Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With CADe (Discovery System) on Adenoma Detection Rate.
Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With Artificial Intelligence Assisted Polyp Detection (Discovery System) on Adenoma Detection Rate. 'Discovery III Study'
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Colonoscopy is the gold standard for colorectal screening. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colon during the procedure. To increase detection new polyp detection systems based on artificial intelligence (AI) have been developed. However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions, or lesions hidden behind folds in the colon. With this study we want to combine a device to flatten the folds in the colon combined with an artificial intelligence system to further improve the detection rate of lesions during colonoscopy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Artificial Intelligence | — | UNRESOLVED | — |
| Colonoscopy | — | UNRESOLVED | — |
| Colorectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- colonoscopy with a combined BFT and CADe assisted approach
- description
- This multicenter single-arm colonoscopy trial will compare colonoscopy assisted by both balloon-BFT visualizing and CADe to CADe-only assisted colonoscopy in diagnostic, screening (non-iFOBT based)), or surveillance colonoscopy. The latter group will be selected from the interventional arm from the Discovery II trial, using corresponding participating centers. All subjects in this trial will undergo the same treatment, i.e., combined balloon and CADe-assisted colonoscopy.
- interventionNames
- Device: colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe)
Primary outcomes (1)
- measure
- Adenoma Detection Rate (ADR)
- timeFrame
- 30 days after procedure
- description
- Calculated as the number of patients in whom at least one adenoma is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure.
Secondary outcomes (19)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>18 years) * Referred and scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy. Exclusion Criteria: * Inflammatory bowel disease (IBD) * Known polyp or tumor upon referral * Therapeutic procedure (e.g., endoscopic mucosal resection) * Prior surgical resection of any portion of the colon * American Society of Anesthesiologists score of ≥3 * Inadequately corrected anticoagulation disorder or anticoagulation medication use * inability to provide informed consent.
References
Publications (1)
- DERIVEDMaas MHJ, van Riswijk MLM, Rath T, Cesaro P, Salvi D, Siersema PD; DISCOVERY III study group. Effect of Combination of a Mucosal Exposure Device and Computer-Aided Detection in Diagnostic, Screening, and Surveillance Colonoscopy: An International, Multicenter Study. Clin Transl Gastroenterol. 2026 Feb 1;17(2):e00963. doi: 10.14309/ctg.0000000000000963. PMID 41363762