Clinical trial · Interventional
Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
Predicting Adenomatous Polyps in the Colon, Using Images of a Human Tongue
- 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)
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Microbiome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gixam | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gixam followed by standard of care colonoscopy
- description
- This is a single-arm study. All participants will undergo the Gixam test following a standard of care colonoscopy
- interventionNames
- Device: Gixam
Primary outcomes (2)
- measure
- Primary Safety Endpoint - Number of device related adverse events and serious adverse events
- timeFrame
- 1 day
- measure
- Primary Efficacy Endpoint - Gixam's diagnostic accuracy
- timeFrame
- 14 days (till pathology report is received)
- description
- Gixam's diagnostic accuracy (sensitivity and specificity) of adenomatous colorectal polyps. The Gixam's predictive value will be compared to the patient's colonoscopy + pathology (if any specimens are collected) findings as ground truth on a binary basis (YES/NO for adenomatous and sessile serrated polyps).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males or females 2. Age: 18-75 years, inclusive 3. Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria: 1. Screening - defined as first colonoscopy or consecutive colonoscopy without previous findings, previous colonoscopy performed at least 10 years ago (- 1 year); 2. Patient with finding of colorectal adenoma or sessile serrated polyp in previous colonoscopy (must be documented in patient's medical history). 4. Able to comprehend and provide informed consent. Exclusion Criteria: 1. Subject who is not a suitable candidate for a colonoscopy 2. Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes 3. Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration 4. Patients with a disability to extend their tongue. 5. Patients with tongue piercings.
References
Publications (0)
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