NCT07606963Active, not recruitingNot Applicable
Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy
Neptune Medical1 site in 1 country40 target enrollmentStarted: August 24, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 protocol specific procedures
- •Subject is willing and able to comply with all protocol required preparation and follow- up visits
Exclusion Criteria
- •Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
- •Any active or magnetic 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
- •Subject 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 Criteria:
- •Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) (Appendix A) score < 2 in any segment.
- •Any intraoperative finding or condition that, in the Investigator's judgment, would make study participation unsafe or not in the subject's best interest (e.g., significant stricture, tight sigmoid colon precluding safe overtube passage).
Arms & Interventions
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.
Intervention: Diagnostic Test: Diagnostic Colonoscopy (Device)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Clinical Outcomes of 3D Printed and Milled Complete DenturesNCT07586774Dentsply Sirona Implants and Consumables68
Recruiting
Not Applicable
TriClip Japan Post-Approval StudyTricuspid RegurgitationNCT07509658Abbott Medical Devices250
Recruiting
Phase 2
Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed/Refractory Primary or Secondary Central Nervous System LymphomaNCT07416890Zhejiang Cancer Hospital24
Not yet recruiting
Phase 2
A Single-arm, Phase II, Multi-center Clinical Trial of Sintilimab During the Perioperative Period in Patients With Resectable Locally Advanced Head and Neck Squamous Cell CarcinomaNCT07379424chen chao Professor37
Recruiting
Phase 1
Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab ImmunotherapyRectal CancerNCT07561060Fudan University50