Colonoscopy With a Robotic Endoscope, The CARE I Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Safety Endpoint - Incidence of Major Adverse Events Within 48 Hours
研究概览
简要总结
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.
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 Clinical Investigation Plan specific procedures
- •Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -
排除标准
- •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
结局指标
主要结局
Safety Endpoint - Incidence 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 any of the following: 1. Device-related death within 48 hours 2. Perforation within 48 hours 3. Intraprocedural bleeding preventing completion of the procedure 4. Delayed bleeding within 48 hours accompanied by pre-defined symptoms and confirmed by a hemoglobin drop of \>2 g, leading to admission to the hospital, prolongation of hospital stay, or another procedure requiring sedation/anesthesia. Unit of Measure: Number of participants with at least one Major Adverse Event
Efficacy Endpoint - Successful Completion of Colonoscopy
时间窗: During procedure
Completion of colonoscopy defined by both: (a) successful cecal intubation (clinically acceptable access and visualization of the cecum), and (b) successful withdrawal (clinically acceptable diagnostic and therapeutic access of the entire colon tract).
次要结局
- Need for Repositioning(During procedure)
- NASA Task Load Index (NASA-TLX)(Post-procedure)
- Delayed Perforation (14 Days)(14 days)
- Polypectomy Success(During procedure)
- Delayed Bleeding (14 Days)(14 days)
- Time to Cecum(During procedure)
- Adenoma Detection Rate (ADR)(During procedure)
- Mucosal Injury Score(During procedure)