Status:
NOT_YET_RECRUITING
Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions
Lead Sponsor:
Neptune Medical
Collaborating Sponsors:
KCRI
H-T. Centrum Medyczne Sp. z o.o. sp. k
Conditions:
Colonoscopy
Colorectal Cancer Screening
Eligibility:
All Genders
22+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥ 22 years
- Adults indicated for elective screening, surveillance or diagnostic colonoscopy
- Subject is willing and able to provide written informed consent prior to receiving any non-standard of care Clinical Investigation Plan specific procedures
- Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -
- 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
Exclusion
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06935734
Start Date
April 14 2025
End Date
July 31 2025
Last Update
April 20 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.