Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions (CARE I)

Neptune Medical

Status: Not yet enrolling

Conditions: Gastrointestinal Endoscopy; Colorectal Neoplasms; Colonoscopy; Colorectal Cancer Screening

Treatments: Diagnostic Test: Diagnostic Colonoscopy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06935734

CP-000001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Single Arm

Other group

Description:

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.

Treatment:

Diagnostic Test: Diagnostic Colonoscopy