Colonoscopy, Colorectal Cancer Screening, Colorectal Neoplasms, Gastrointestinal Endoscopy
Conditions
Brief summary
This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.
Interventions
DIAGNOSTIC_TESTDiagnostic Colonoscopy
Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.
Sponsors
KCRI
H-T. Centrum Medyczne Sp. z o.o. sp. k
Neptune Medical
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 Clinical Investigation Plan specific procedures 4. Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -
Exclusion criteria
Initial Screening / Pre-Operative: 1. Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator. 2. Any active 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. Patient 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint - Incidence 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 any of the following: 1. Device-related death within 48 hours 2. Perforation within 48 hours 3. Intraprocedural bleeding preventing completion of the procedure 4. Delayed bleeding within 48 hours accompanied by pre-defined symptoms and confirmed by a hemoglobin drop of \>2 g, leading to admission to the hospital, prolongation of hospital stay, or another procedure requiring sedation/anesthesia. Unit of Measure: Number of participants with at least one Major Adverse Event |
| Efficacy Endpoint - Successful Completion of Colonoscopy | During procedure | Completion of colonoscopy defined by both: (a) successful cecal intubation (clinically acceptable access and visualization of the cecum), and (b) successful withdrawal (clinically acceptable diagnostic and therapeutic access of the entire colon tract). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polypectomy Success | During procedure | If applicable, indicates whether at least one polyp was successfully removed using standard polypectomy tools during the procedure. This outcome is evaluated per participant and applies only to Phase B (robotic procedures). Unit of Measure: Categorical - Yes / No / Partial (i.e., at least one polyp removed, but not all targeted polyps). |
| NASA Task Load Index (NASA-TLX) | Post-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 (0-100) |
| Mucosal Injury Score | During procedure | Mucosal injury graded using a 5-point ordinal scale based on injury severity: 1 = Erythema/ Bruising, 2 = Mucosal break \<5mm in length, 3 = Mucosal break \>5mm in length, 4 = Mucosal Injury (non-full thickness), 5 = Full thickness injury. Outcome is reported per subject. Only applicable to Phase B (robotic procedures). Unit of Measure: Score (1-5); higher scores indicate more severe injury |
| Time to Cecum | During procedure | Time from scope insertion to successful cecal intubation. Unit of Measure: Minutes |
| Delayed Perforation (14 Days) | 14 days | Number of participants with delayed perforation identified within 14 days post-procedure. Unit of Measure: Number of participants |
| Adenoma Detection Rate (ADR) | During procedure | Proportion of participants in whom at least one adenomatous polyp is detected during the robotic colonoscopy procedure. Applicable to Phase B (robotic procedures) only. Unit of Measure: Percentage of participants with ≥1 adenoma detected |
| Delayed Bleeding (14 Days) | 14 days | Number of participants with delayed bleeding within 14 days confirmed by pre-determined symptoms and hemoglobin drop of \>2 g/dL. Unit of Measure: Number of participants |
| Need for Repositioning | During procedure | Number of times a participant was repositioned to facilitate scope advancement. Unit of Measure: Number of repositioning events |
Contacts
Primary ContactAishwarya Gosai
Outcome results
None listed