NCT04196062已完成不适用
Prospective, Single Arm Study to Assess the Safety and Performance of the EndoMaster EASE System for the Treatment of Colorectal Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Complete (R0) resection
研究概览
简要总结
This is a prospective, single arm study to assess the safety and performance of the EndoMaster EASE (Endoluminal Access Surgical Efficacy) System for the treatment of patients with colorectal neoplasms.
详细描述
Prospective, single arm study to assess the safety and performance of robotically assisted ESD of superficial colorectal lesions, that otherwise cannot be optimally and radically removed by snare-based techniques
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 85;
- •Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.
排除标准
- •Informed consent not available;
- •Carcinoma of colon or rectum with known involvement beyond the submucosa;
- •Evidence of distant spread of colon cancer;
- •Presence of another active malignancy;
- •Patients considered unfit for general anaesthesia;
- •The endoscopic platform cannot reach the target site;
- •Current participation in another clinical research study.
结局指标
主要结局
Complete (R0) resection
时间窗: 30 days
rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins
次要结局
- Duration of procedure(1 day)
- Length of Hospital stay(30 days)
- Adjunctive procedures to control bleeding(1 day)
- Bleeding during or after the procedure(30 days)
- Perforation(30 days)
- All cause mortality(30 days)
- Infection(30 days)
- Impairment of renal function(30 days)
- Serious Adverse Events(30 days)
- Operator assessment of device performance(1 day)
- Device deficiencies(1 day)
- Colonoscopy followup(6 months, 18 months to 3 years)
- Cancer status by cross-sectional imaging (MRI / CT)(12 months and 3 years)
- Technical Success(30 days)
- Histology of resected specimen(30 days)
研究者
Philip Wai Yan CHIU
Professor
Chinese University of Hong Kong
研究点 (2)
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