Clinical trial NCT06935734: Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions
Official title: Colonoscopy With a Robotic Endoscope, The CARE I Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colonoscopy
Colorectal Cancer Screening
Colorectal Neoplasms
Gastrointestinal Endoscopy
Lead sponsor: Neptune Medical
Sponsor class: INDUSTRY
Collaborators: name: KCRI
name: H-T. Centrum Medyczne Sp. z o.o. sp. k
First posted: 2025-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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 Exclusion Criteria:
21. Inadequate Bowel Preparation, Boston Bowel Prep Scale Score (after cleansing) \< 2 in any section
22. Failed conventional colonoscopy or polypectomy/biopsy performed during the conventional colonoscopy procedure in Phase A
23. 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
24. 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

Primary outcomes:
measure: Safety Endpoint - Incidence of Major Adverse Events Within 48 Hours
timeFrame: 48 hours
measure: Efficacy Endpoint - Successful Completion of Colonoscopy
timeFrame: During procedure
Secondary outcomes:
measure: Time to Cecum
timeFrame: During procedure
measure: Need for Repositioning
timeFrame: During procedure
measure: Polypectomy Success
timeFrame: During procedure
measure: NASA Task Load Index (NASA-TLX)
timeFrame: Post-procedure
measure: Mucosal Injury Score
timeFrame: During procedure
measure: Delayed Bleeding (14 Days)
timeFrame: 14 days
measure: Delayed Perforation (14 Days)
timeFrame: 14 days
measure: Adenoma Detection Rate (ADR)
timeFrame: During procedure
Other outcomes:
Locations:
Study officials:
affiliation: H-T Centrum Medyczne
name: Marcin Romanczyk
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Jason Samarasena, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H-T Centrum Medyczne
name: Tomasz Romanczyk
role: PRINCIPAL_INVESTIGATOR
References: