Colonoscopy, Colorectal Cancer Screening
Conditions
Keywords
Colonoscopy, Colorectal Neoplasms, Gastrointestinal Endoscopy
Brief summary
This study is a prospective, single-arm, non-randomized, single-site study, focused on evaluating the safety and efficacy of the Triton 1.5 System in diagnostic and basic therapeutic colonoscopy.
Detailed description
This study is a prospective clinical investigation designed to evaluate the safety, and efficacy of the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤ 2cm). Up to 40 subjects will undergo robotic colonoscopy using the Triton 1.5 System with three operating physicians.
Interventions
DEVICEDiagnostic Test: Diagnostic Colonoscopy
This study will serve 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).
Sponsors
Neptune Medical
KCRI
H-T. Centrum Medyczne Sp. z o.o. sp. k
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum). 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours | 48 Hours | 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 |
| Primary Efficacy Endpoint - Successful Completion of Colonoscopy During Procedure | During Procedure | Completion of colonoscopy defined by both: (a) Successful cecal intubation with visualization of the appendiceal orifice, (b) Successful withdrawal with clinically acceptable diagnostic inspection and therapeutic access. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoint - Mucosal Injury Score During Procedure | During Procedure | Mucosal Injury graded using a visual assessment of the colonic wall during withdrawal of the procedure using the following scale: (1) Erythema / Bruising, (2) Mucosal break \< 5 mm, (3) Mucosal break \> 5 mm, (4) Muscle injury (non-full thickness), (5) Full-thickness injury. Unit of Measure: Score (1-5), higher scores indicate more severe injury |
| Secondary Safety Endpoint - Delayed Bleeding Within 14 Days | 14 days post-procedure | Delayed bleeding within 14 days, defined as: bleeding within 48 hours accompanied by pre-defined symptoms and confirmed by a hemoglobin drop \> 2 g, leading to admission to hospital, prolongation of existing hospital stay, another procedure (requiring sedation/anesthesia). |
| Secondary Safety Endpoint - Delayed Perforations Within 14 Days | 14 days post-procedure | Delayed perforations within 14 days, defined as: perforations occurring within 14 days post-procedure. |
| Secondary Efficacy Endpoint - Time to Cecum During Procedure | During Procedure | Interval from nested-system insertion at the anal verge to first visualization of the appendiceal orifice. Pauses for ancillary or therapeutic tasks (e.g., biopsy, polypectomy ≤ 2 cm, repositioning, prolonged washing) are recorded and subtracted to isolate insertion performance. For polypectomy pauses, time is measured from first polyp visualization to confirmation of retrieval in the specimen trap. Unit of Measure: Minutes or seconds |
| Secondary Efficacy Endpoint - Need for Repositioning During Procedure | During Procedure | Number of times a participant was repositioned during the procedure. Unit of Measure: Number of repositioning events |
| Secondary Efficacy Endpoint - Polypectomy Success During Procedure | During Procedure | Clinically acceptable polypectomy performed with cold forceps, cold snare, or hot snare leaving no visible residual polyp. Polyps \> 2 cm or lesions too complex for diagnostic colonoscopy are excluded and deferred for later advanced therapy. |
| Secondary Efficacy Endpoint - NASA Task Load Index (NASA-TLX) Post-Procedure | Immediately after Procedure | Physician's subjective workload assessment using the NASA Task Load Index (NASA-TLX), a validated tool consisting of six subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale is scored from 0 to 100 in increments of 5. Higher scores indicate greater perceived workload. Unit of Measure: Composite score (0-600) |
| Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure | During Procedure | Percentage of subjects with ≥ 1 histologically confirmed adenoma or carcinoma Unit of Measure: Percentage of participants |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORMarcin Romanczyk, MD
H-T Centrum Medyczne
Outcome results
None listed