Triton 1.5 Robotic System for Diagnostic Colonoscopy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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).

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Польша · 1 центр

• HT Centrum Medyczne — Tychy

Идентификаторы

NCT: NCT07606963 · CP-000005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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