Not yet recruiting NCT06935734
Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic Colonoscopy.
- Who it may be relevant to
- Registry conditions: Colonoscopy, Colorectal Cancer Screening, Colorectal Neoplasms, Gastrointestinal Endoscopy. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Colonoscopy With a Robotic Endoscope, The CARE I Study
Overview
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.
Interventions
- Diagnostic test Diagnostic Colonoscopy
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.
Primary outcome measures
- Safety Endpoint - Incidence of Major Adverse Events Within 48 Hours [Time frame: 48 hours]
- Efficacy Endpoint - Successful Completion of Colonoscopy [Time frame: During procedure]
Secondary outcome measures (8)
- Time to Cecum [Time frame: During procedure]
- Need for Repositioning [Time frame: During procedure]
- Polypectomy Success [Time frame: During procedure]
- NASA Task Load Index (NASA-TLX) [Time frame: Post-procedure]
- Mucosal Injury Score [Time frame: During procedure]
- Delayed Bleeding (14 Days) [Time frame: 14 days]
- Delayed Perforation (14 Days) [Time frame: 14 days]
- Adenoma Detection Rate (ADR) [Time frame: During procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06935734 · CP-000001