Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| KCRI | OTHER |
| H-T. Centrum Medyczne Sp. z o.o. sp. k | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test: Diagnostic Colonoscopy | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint - Incident of Major Adverse Events within 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 | 48 Hours |
| Primary Efficacy Endpoint - Successful Completion of Colonoscopy 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. | During Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoint - Mucosal Injury Score 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Intra-Operative Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hayley Holm | Contact | (650) 922-5512 | hayley.holm@neptunemedical.com | |
| Min-Sun Son | Contact | (650) 714-1803 | minsun@neptunemedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcin Romanczyk, MD | H-T Centrum Medyczne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HT Centrum Medyczne | Tychy | Silesian Voivodeship | 43-100 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| During Procedure |
| Secondary Safety Endpoint - Delayed Bleeding Within 14 Days | 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). | 14 days post-procedure |
| Secondary Safety Endpoint - Delayed Perforations Within 14 Days | Delayed perforations within 14 days, defined as: perforations occurring within 14 days post-procedure. | 14 days post-procedure |
| Secondary Efficacy Endpoint - Time to Cecum 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 | During Procedure |
| Secondary Efficacy Endpoint - Need for Repositioning During Procedure | Number of times a participant was repositioned during the procedure. Unit of Measure: Number of repositioning events | During Procedure |
| Secondary Efficacy Endpoint - Polypectomy Success 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. | During Procedure |
| Secondary Efficacy Endpoint - 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 (0-600) | Immediately after Procedure |
| Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure | Percentage of subjects with ≥ 1 histologically confirmed adenoma or carcinoma Unit of Measure: Percentage of participants | During Procedure |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |