Clinical trial · Interventional
Triton 1.5 Robotic System for Diagnostic Colonoscopy in the Middle East
Early Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy in the Middle East
NCT07835542CI-TRIAL-00126541CARE-UAEnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of this study is to gain early experience in the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤ 2 cm). This study will be the first clinical experience with Triton 1.5 in the Middle East, conducted at Cleveland Clinic Abu Dhabi.
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 |
|---|---|---|---|
| Colonoscopy | — | UNRESOLVED | — |
| Colorectal Cancer Screening | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Test: Diagnostic Colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm
- description
- This study is a prospective, single-arm, non-randomized, single-site study, which is deigned to evaluate the safety and efficacy of the Triton 1.5 System for performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤2cm) during endoscopic procedures.
- interventionNames
- Device: Diagnostic Test: Diagnostic Colonoscopy
Primary outcomes (2)
- measure
- Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours
- timeFrame
- 48 Hours
- description
- Absence of Major Adverse Events (MAEs) within 48 hours of the procedure. MAEs are defined as the following: (a) Device-related death within 48 hours, (b) Perforation within 48 hours, (c) Intraprocedural bleeding preventing completion of the procedure, (d) Delayed bleeding within 48 hours accompanied by predefined symptoms and confirmed by a hemoglobin drop of \>2 g, as applicable, leading to admission to hospital, prolongation of existing hospital stay, another procedure (requiring sedation/anesthesia). Unit of Measure: Number of participants with at least one Major Adverse Event
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 22 years 2. Adults indicated for elective screening, surveillance or diagnostic colonoscopy 3. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures 4. Subject is willing and able to comply with all protocol required preparation and follow- up visits Exclusion Criteria: 1. Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator. 2. Any active or magnetic implantable medical devices (e.g., pacemakers, defibrillators) 3. Previous failed colonoscopy (except for inadequate bowel preparation) 4. BMI \> 45 kg/m2 5. Pregnant participants 6. Surgically altered colonic anatomy 7. History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, hereditary nonpolyposis colorectal cancer (Lynch) syndrome, sclerosing encapsulating peritonitis, active diverticulitis in last 6 months or toxic megacolon 8. Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day 9. Known bleeding tendency such as hemophilia or coagulation factor deficiencies 10. Subject receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin 11. Known colonic stricture 12. Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment 13. Known abdominal wall hernias 14. History of radiotherapy to the abdomen or pelvis 15. History of mesenteric ischemia 16. Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure 17. Contraindication to the proposed sedation / anesthesia 18. Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure 19. Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure 20. Participation in any concurrent clinical trial that may impact the results of this study Intra-Operative Criteria: 1. Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) (Appendix A) score \< 2 in any segment. 2. Any intraoperative finding or condition that, in the Investigator's judgment, would make study participation unsafe or not in the subject's best interest (e.g., significant stricture, tight sigmoid colon precluding safe overtube passage).
References
Publications (0)
Data not yet available
No reference posted for this study.