PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 7
- 主要终点
- En Bloc Resection Rate
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.
The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.
详细描述
This study will be a prospective, single treatment, multi-center, open-label clinical study. The objective of this study is to evaluate the safety and effectiveness of the ELS System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon (up to 7 cm in size and up to 75% of the colorectal circumference).
The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge, Day 7 (-2 +7 days) and Day 30 (-7 +14 days).
Subjects with lesions resected using the study device will be allocated into two different study arms:
Arm 1:
- Subjects with benign final pathology and R0 resection is achieved; or,
- Subjects with benign (but not pre-cancerous) final pathology without R0 resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Preoperative Inclusion Criteria:
- •Subject is ≥22 years at the time of consent.
- •Subject has a BMI ≤ 50 kg/m
- •Subject has an ASA score of ≤
- •Subject has benign lesion(s) of the rectum or sigmoid colon, such as adenoma (with low- or high-grade dysplasia), neuroendocrine tumor, or other type of polyp as assessed by the most recent colonoscopy/flexible sigmoidoscopy.
- •Subject has lesion ≤ 7 cm in size (dimension of greatest extent) and ≤ 75% of the colorectal circumference as assessed by the most recent colonoscopy/flexible sigmoidoscopy.
- •Subject is eligible for standard endoscopic submucosal dissection.
- •Subject agrees to participate in the study by giving signed informed consent.
- •Preoperative
排除标准
- •Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
- •Subject has active left-sided inflammatory bowel disease.
- •Subject has an untreated active infection at the time of the procedure.
- •Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled).
- •Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer).
- •Subject is breastfeeding or pregnant or intends to become pregnant during the study.
- •Subject is 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.
- •Subject with EF ≤ 45, high cardiac or high pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist, as applicable).
- •Subject on preoperative blood thinners, such as coumadin or heparin, that cannot be weaned prior to surgery.
- •Subject is moderately or severely immunocompromised.
- •In the opinion of the Investigator, the subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
- •Intraoperative Exclusion Criteria (assessed with third-party endoscope):
- •Inadequate bowel prep.
- •Complex anatomical findings not feasible for an endoluminal approach.
- •Anatomical narrowing distal to the lesion site.
- •Lesion not located in the rectum or sigmoid colon.
- •Lesion size >7 cm (dimension of greatest extent) or occupies >75% of the colorectal circumference.
- •Lesion demonstrates characteristics indicative of invasive carcinoma, such as failure to lift upon submucosal injection, or any other features that raise the Investigator's suspicion of cancer.
- •Intraoperative Exclusion Criteria (assessed with study device):
- •In the opinion of the Investigator, the subject and/or subject anatomy is not suitable for study device use for any reason.
- •Lesion location not accessible by the study device.
研究组 & 干预措施
Arm 1
- Subjects with benign final pathology and R0 resection is achieved; or,
- Subjects with benign (but not pre-cancerous) final pathology without R0 resection.
Subjects in Arm 1 will complete the study after Day 30.
干预措施: Endoscopic submucosal dissection using the ELS System (Device)
Arm 2
- Subjects with final pathology that is upstaged to cancer; or,
- Subjects with benign (and pre-cancerous) final pathology without R0 resection.
Subjects in Arm 2 will undergo 5-year follow-up to assess long-term oncological outcomes including local recurrence, disease-free survival and overall survival.
干预措施: Endoscopic submucosal dissection using the ELS System (Device)
结局指标
主要结局
En Bloc Resection Rate
时间窗: On Day 0 (day of procedure)
The percentage of target lesions across all subjects that are excised in a single specimen.
ESD-Related Complication-Free Rate
时间窗: From enrollment to Day 30.
The percentage of subjects free from study device-related bleeding and perforation complications intraoperatively and postoperatively through Day 30.
次要结局
- R0 Resection Rate(On Day 0 (day of procedure))
- Conversion-Free Rate(On Day 0 (day of procedure))