NCT07606963进行中（未招募）不适用
Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy
Neptune Medical1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年8月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Diagnostic Test: Diagnostic Colonoscopy (Device)
研究者
研究点 (1)
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