Endoscopic Resection of Colorectal Lesions with ColubrisMX Endoluminal Surgical System (ELS for Its Initials in English), Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Readmission rate (%)
研究概览
简要总结
This study is a prospective, single-arm, open-label, multi-center, feasibility study to evaluate the safety and efficacy of the ColubrisMX ELS System in patients undergoing transanal endoluminal procedures, specifically colorectal Endoscopic Submucosal Dissection.
详细描述
Endoscopic resection of small polyps is performed routinely through conventional outpatient colonoscopy. Larger polyps or incipient tumors can be excised with endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). These minimally invasive procedures have been shown to be viable alternatives to conventional surgical resections with less risk of complications, shorter hospital stay and lower costs.
Both flexible endoscopic and open/laparoscopic surgical approaches have procedural limitations that can have considerable impact on patient care. Traditional endoscopic tools have technical inadequacies that may inhibit the physician's ability to complete more complex tasks consistent with a surgical technique. Conversely, a traditional open or laparoscopic surgical approach involves increased risk of complications (such as surgical site infection), increased pain and blood loss, longer recovery, and surgical scars. The objective of this clinical study is to assess the safety and efficacy of the ColubrisMX Endoluminal Surgical (ELS) System, a new robotic technology designed to assist the physician with precision, flexibility, and control during endoluminal removal of colorectal lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following criteria must be present to be eligible for the study:
- •Aged 18-75 years
- •BMI ≤ 35 kg/m2
- •Patient agrees to participate in the study by giving signed informed consent
- •Benign lesions of the rectum, such as adenoma, submucosal nodule, or polyp
- •Mucosal neoplasm
- •Eligible to undergo standard endoscopic submucosal dissection.
- •Patient reviewed and approved by Local Oncology Committee to undergo robotic procedure.
排除标准
- •Patients will be excluded from the study if any of the following criteria are present:
- •Preoperative
- •Anatomy unsuitable for endoscopic visualization or endoluminal surgery
- •Extensive previous surgery in the lower GI tract
- •Prior radiation treatment for colorectal cancer
- •Patient with distant metastases
- •Untreated active infection
- •Vulnerable population (e.g., prisoners, mentally disabled)
- •Severe concomitant illness (i.e., cancer) that drastically shortens life expectancy or increases risk of therapeutic interventions
- •Breastfeeding or pregnant, or intend to become pregnant during the course of the study
- •Currently enrolled in or discontinued within the last 30 days from a clinical trial of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •In the opinion of the Investigator, the patient is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
- •Patients with immunosuppression drugs (chemotherapy) due to an increase potential infection and poor healing
- •Patients with a high cardiac or pulmonary risk (these patients require clearance from a cardiologist and pulmonologist)
- •Preoperative blood thinner i.e., coumadin or heparin.
- •Obstructing rectal cancer
- •History of inflammatory bowel disease
- •Intraoperative
- •Existing stricture or anatomical blockage in lower GI tract preventing overtube from reaching desired position.
- •Disease is more extensive and not amenable to standard ESD
- •Inadequate bowel prep
- •Complex anatomical findings not feasible for endoscopic approach
研究组 & 干预措施
Robotic Transanal Endoluminal Resection
Robotic Transanal Endoluminal Resection of Colorectal Lesions
干预措施: ColubrisMX Endoluminal Surgical (ELS) System (Device)
结局指标
主要结局
Readmission rate (%)
时间窗: 60 Days
Percentage of patients with readmission that can be linked to colorectal submucosal dissection.
Rate of success (%)
时间窗: 24 hours post-op
Percentage of patients with no conversion during surgery and no major complications (Clavien-Dindo ≥ III complication rating) for 24 hours post-op.
Rate of conversions (%)
时间窗: Intraoperative
Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure.
Estimated blood loss (mL)
时间窗: Intraoperative
Estimated amount of intraoperative blood loss (up to the point of needing transfusion).
Operative time (min)
时间窗: Intraoperative
Duration from transanal insertion of the robotic flexible overtube to final removal of the flexible overtube from the anal verge.
Patients requiring transfusion (%)
时间窗: Intraoperative
Percentage of patients requiring transfusion during surgery.
Complication rate (%)
时间窗: 60 Days
Percentage of patients having Clavien-Dindo ≥ III intraoperatively or postoperatively at Days 7, 30, or 60.
Major Adverse Events (MAE) during the first 60 days
时间窗: 60 Days
Freedom from procedural-related MAE, defined as a combined clinical endpoint of death or reoperation for failed surgical repair.
次要结局
未报告次要终点