NCT07146165尚未招募不适用
Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:
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
- 6
- 主要终点
- Technical success of the endoscopic resection
研究概览
简要总结
The goal of this clinical trial is to determine whether the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon is feasible and safe.
The main questions it aims to answer are:
- Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon feasible (i.e., does it enable complete resection of the polyp)?
- Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon safe?
Participants will:
- be treated with the EndoTEM system during the endoscopic submucosal dissection of polyps in the distal colon.
- answere questionnaires on fecal continence and quality of life before and after the intervention.
- be treated following standard clinical procedures before, during and after the endoscopic removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Availability of written informed consent from the patient
- •Age > 18 years
- •Adenoma or early carcinoma > 2 cm in the rectum or distal sigmoid colon with indication for endoscopic en bloc resection using endoscopic submucosal dissection
排除标准
- •Informed consent not possible (e.g., language barrier)
- •Stenoses or fistulas in the anal region
- •Distance to the anocutaneous line ≤ 2 cm
- •Distance to the anocutaneous line > 20 cm
- •Individual medical assessment required for patients taking anticoagulant medication, in accordance with current ESGE guidelines
- •Pregnancy or breastfeeding
- •Vulnerable individuals
结局指标
主要结局
Technical success of the endoscopic resection
时间窗: From the endoscopic resection to the follow-up endoscopy after 6 months.
Macroscopically complete resection.
次要结局
- R0 resection rate(Assessed with a biopsy collected during the intervention.)
- En bloc resection rate(Assessed during the intervention.)
- Duration of the procedure(From endoscope insertion until the end of procedure including supplementary and prophylactic interventions.)
- Resection time(From start of the resection until detachment of the specimen.)
- Resection speed(Assessed during the intervention.)
- Periprocedural complications(Complications that occur during or immediately around the intervention (until 3-6 months post-intervention).)
- Requirement for surgical intervention(During the endoscopic submucosal dissection.)
- Rate of recurrence(Assessed during follow-up endoscopy 3-6 months post-intervention.)
研究者
研究点 (6)
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