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โ† Trials
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Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer

RecruitingNAAges 18 Years - 80 YearsAllShandong University
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are: Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system. Participants will: Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system. Keep a diary of their

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients aged 18-80. * Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach. Exclusion Criteria: * Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis. * Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery. * Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure. * Patients have lesions with local recurrence after endoscopic resection. * Patients unable to obtain informed consent.
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What it tests

  • FASTER-assisted ESD
  • Conventional ESD
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Where

1 site
Qilu Hospital of Shandong University
Jinan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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