Clinical trial · Interventional
Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer
NCT06688110CI-TRIAL-00082522not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.
Conditions
Conditions (3)
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 Adenomatous Polyp | Colorectal Adenomatous Polyp | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gixam System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gixam followed by standard of care colonoscopy
- description
- All enrolled participants will undergo the Gixam test followed by a standard of care colonoscopy
- interventionNames
- Device: Gixam System
Primary outcomes (2)
- measure
- Safety - number of device related adverse events and serious adverse events
- timeFrame
- Through study completion, up to 30 days
- description
- Number of device related adverse events and serious adverse events
- measure
- Efficacy - Gixam's sensitivity and specificity
- timeFrame
- Through study completion, up to 30 days
- description
- Gixam's sensitivity and specificity to predict the presence of premalignant neoplastic colorectal polyps (advanced premalignant neoplastic lesions/non-advanced premalignant neoplastic lesion) and CRC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects aged ≥50 - ≤80 years. 2. Able to provide a signed informed consent. 3. Underwent FIT screening within the past 6 months with a positive result. 4. Scheduled for a FIT positive screening colonoscopy at investigational site. Exclusion Criteria: 1. Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention. 2. Personal history of CRC. 3. Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age. 4. Subject has a diagnosis or medical / family history of any of the following conditions, including: * Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome), * Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"), * Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis. 5. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis, and/or Crohn's disease, and/or IBD-undefined. 6. Subjects with the disability to extend their tongue. 7. Subjects with tongue piercing. 8. Dental visit in the 7 days prior to the Gixam test. 9. Intake of pro-biotics over the past 3 months pre-Gixam test. 10. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.