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| Name | Class |
|---|---|
| KCRI | OTHER |
| H-T. Centrum Medyczne Sp. z o.o. sp. k | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where the first phase (A) will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and the second phase (B) will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Colonoscopy | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Unit of Measure: Number of participants with at least one Major Adverse Event | 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). | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cecum | Time from scope insertion to successful cecal intubation. Unit of Measure: Minutes | During procedure |
| Need for Repositioning | Number of times a participant was repositioned to facilitate scope advancement. Unit of Measure: Number of repositioning events |
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Inclusion Criteria
Exclusion Criteria:
Initial Screening / Pre-Operative:
Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
Any active implantable medical devices (e.g., pacemakers, defibrillators)
Previous failed colonoscopy (except for inadequate bowel preparation)
BMI > 45 kg/m2
Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).
Surgically altered colonic anatomy
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
Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
Known bleeding tendency such as hemophilia or coagulation factor deficiencies
Patient receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin
Known colonic stricture
Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment
Known abdominal wall hernias
History of radiotherapy to the abdomen or pelvis
History of mesenteric ischemia
Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure
Contraindication to the proposed sedation / anesthesia
Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure
Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure
Participation in any concurrent clinical trial that may impact the results of this study
Intra-Operative Exclusion Criteria:
Inadequate Bowel Preparation, Boston Bowel Prep Scale Score (after cleansing) < 2 in any section
Failed conventional colonoscopy or polypectomy/biopsy performed during the conventional colonoscopy procedure in Phase A
Any presenting condition discovered intraoperatively that in the opinion of the investigator would make participating in this study not in the participant's/patient's best interest. For example, presence of a stricture or tight sigmoid that would make passing an overtube risky for the patient
Any condition, in the opinion of the Investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aishwarya Gosai | Contact | (949) 394 8073 | aishwarya@neptunemedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcin Romanczyk | H-T Centrum Medyczne | Principal Investigator |
| Jason Samarasena, MD | University of California, Irvine | Principal Investigator |
| Tomasz Romanczyk |
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|
| 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). | 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) | 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 | 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 | 14 days |
| Delayed Perforation (14 Days) | Number of participants with delayed perforation identified within 14 days post-procedure. Unit of Measure: Number of participants | 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 | During procedure |
| H-T Centrum Medyczne |
| Principal Investigator |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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