Early Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy in the Middle East
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours
研究概览
简要总结
The purpose of this study is to gain early experience in the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤ 2 cm). This study will be the first clinical experience with Triton 1.5 in the Middle East, conducted at Cleveland Clinic Abu Dhabi.
详细描述
The study will include up to 10 patients for operator training and familiarization with the Triton 1.5 System. Data from the training phase will be collected for operational and safety review but will not contribute to the primary or secondary endpoint analyses. Up to 20 subjects will undergo robotic colonoscopy to evaluate the performance of Triton 1.5 System in diagnostic, screening, surveillance colonoscopies, which are inclusive of basic therapeutic tasks, such as polypectomy for lesions ≤ 2 cm.
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
- •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
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)
结局指标
主要结局
Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours
时间窗: 48 Hours
Absence of Major Adverse Events (MAEs) within 48 hours of the procedure. MAEs are defined as the following: (a) Device-related death within 48 hours, (b) Perforation within 48 hours, (c) Intraprocedural bleeding preventing completion of the procedure, (d) Delayed bleeding within 48 hours accompanied by predefined symptoms and confirmed by a hemoglobin drop of \>2 g, as applicable, leading to admission to hospital, prolongation of existing hospital stay, another procedure (requiring sedation/anesthesia). Unit of Measure: Number of participants with at least one Major Adverse Event
Primary Efficacy Endpoint - Successful Completion of Colonoscopy During Procedure
时间窗: During Procedure
Completion of colonoscopy defined by both: (a) Successful cecal intubation with visualization of the appendiceal orifice, (b) Successful withdrawal with clinically acceptable diagnostic inspection and therapeutic access.
次要结局
- Secondary Safety Endpoint - Mucosal Injury Score During Procedure(During Procedure)
- Secondary Safety Endpoint - Delayed Bleeding Within 14 Days(14 days Post-Procedure)
- Secondary Safety Endpoint - Delayed Perforations Within 14 Days(14 days Post-Procedure)
- Secondary Efficacy Endpoint - Time to Cecum During Procedure(During Procedure)
- Secondary Efficacy Endpoint - Need for Repositioning During Procedure(During Procedure)
- Secondary Efficacy Endpoint - Polypectomy Success During Procedure(During Procedure)
- Secondary Efficacy Endpoint - NASA Task Load Index (NASA-TLX) Post-Procedure(Immediately after Procedure)
- Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure(Within 30 days Post-Procedure)
- Secondary Efficacy Endpoint - Patient-Reported Discomfort(Up to 24 Hours Post-Procedure)