Not yet recruiting NCT07606963

Triton 1.5 Robotic System for Diagnostic Colonoscopy

No phase Interventional Colonoscopy Colorectal Cancer Screening Colorectal Neoplasms Gastrointestinal Endoscopy

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 Test: 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: Poland
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy

Overview

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.

Interventions

Device Diagnostic Test: Diagnostic Colonoscopy
This study will serve 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).

Primary outcome measures

Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours [Time frame: 48 Hours]
Primary Efficacy Endpoint - Successful Completion of Colonoscopy During Procedure [Time frame: During Procedure]

Secondary outcome measures (8)

Secondary Safety Endpoint - Mucosal Injury Score During Procedure [Time frame: During Procedure]
Secondary Safety Endpoint - Delayed Bleeding Within 14 Days [Time frame: 14 days post-procedure]
Secondary Safety Endpoint - Delayed Perforations Within 14 Days [Time frame: 14 days post-procedure]
Secondary Efficacy Endpoint - Time to Cecum During Procedure [Time frame: During Procedure]
Secondary Efficacy Endpoint - Need for Repositioning During Procedure [Time frame: During Procedure]
Secondary Efficacy Endpoint - Polypectomy Success During Procedure [Time frame: During Procedure]
Secondary Efficacy Endpoint - NASA Task Load Index (NASA-TLX) Post-Procedure [Time frame: Immediately after Procedure]
Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure [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 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).

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

Poland · 1 center

HT Centrum Medyczne — Tychy

Identifiers

NCT: NCT07606963 · CP-000005

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗