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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
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.
Safety Endpoint - Incidence of Major Adverse Events Within 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
Time frame: 48 hours
Efficacy Endpoint - Successful Completion of Colonoscopy
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).
Time frame: During procedure
Time to Cecum
Time from scope insertion to successful cecal intubation. Unit of Measure: Minutes
Time frame: During procedure
Need for Repositioning
Number of times a participant was repositioned to facilitate scope advancement. Unit of Measure: Number of repositioning events
Time frame: During procedure
Polypectomy Success
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).
Time frame: During procedure
NASA Task Load Index (NASA-TLX)
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)
Time frame: Post-procedure
Mucosal Injury Score
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 frame: During procedure
Delayed Bleeding (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
Time frame: 14 days
Delayed Perforation (14 Days)
Number of participants with delayed perforation identified within 14 days post-procedure. Unit of Measure: Number of participants
Time frame: 14 days
Adenoma Detection Rate (ADR)
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
Time frame: During procedure
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