Feasibility and Added Value of the TRACMOTION Device for ESD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Dissection speed
研究概览
简要总结
A single center non-randomized prospective clinical study, to evaluate the feasibility and added value of the CE-certified Tracmotion device in patients scheduled consecutively for ESD in the upper and lower gastrointestinal tract.
After ESD, the endoscopists' opinion will be evaluated with a short questionnaire on experience with the Tracmotion device. The pathology report will be checked for radicality and microscopic damage of the removed lesion.
详细描述
Objective: The purpose of this study is to establish feasibility of the Tracmotion device for ESD and to define its added value during ESD in both upper and lower GI procedures, both in antegrade and in retroflex positions.
Study design: Single center prospective observational non-randomized clinical study.
Study population: A total of 20 consecutive cases scheduled for ESD will be included. Sample size calculation does not apply for this type of study. Patients already scheduled for ESD will undergo an ESD procedure as planned with the aid of the Tracmotion device. It is anticipated that the Tracmotion will provide superior traction and counter traction compared to off-label tools.
Intervention: Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device.
Main study parameters/endpoints:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for endoscopic submucosal dissection (upper and lower gastrointestinal tract);
- •Lesion is accessible with a therapeutic endoscope;
- •Written informed consent;
- •Age ≥18 years.
排除标准
- •Coagulopathy (not corrected prior to endoscopic submucosal dissection);
- •Participating in a different experimental drug/device trial in the previous 3 months.
研究组 & 干预措施
ESD with TRACMOTION
Patients already scheduled for ESD will undergo an ESD procedure with the aid of the TRACMOTION device.
干预措施: TRACMOTION (Device)
结局指标
主要结局
Dissection speed
时间窗: During endoscopic submucosal dissection procedure
Dissection speed of ESD will be measured from start incision to end incision (square millimeter of dissected tissue per minute)
Procedure time
时间窗: During endoscopic submucosal dissection procedure
Procedure time of the endoscopic submucosal dissection will be measured from start incision to end incision (in minutes)
Subjective evaluation of the added value of the TRACMOTION device
时间窗: Immediately after endoscopic submucosal dissection
Directly after the endoscopic mucosal dissection the endoscopist will fill in a questionnaire using the Likert scale (1= worst experience possible, 5 = best experience possible) about their experience with the TRACMOTION device during ESD (overall contentment, difference of procedure time, stability of, control of and accessibility to the lesion that was resected)
Lesional damage
时间窗: During endoscopic submucosal dissection and during pathology review (on average 2 weeks after endoscopic submucosal dissection)
Any tearing or grasping injury to the mucosa on macroscopy (yes vs. no) observed by the endoscopist and at pathological review (yes/no) observed by the pathologist expressed in percentages (%).
次要结局
- R0 rate(Determined during the pathology review (on average 2 weeks after endoscopic submucosal dissection))
- En-bloc rate(Determined Immediately after endoscopic submucosal dissection)
- Complications after during and after endoscopic submucosal dissection(During endoscopic submucosal dissection procedure and 2 weeks after)
研究者
Arjun D. Koch, MD, PhD
Principal Investigator
Erasmus Medical Center