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A Novel Two-Tooth Clip for ESD and EFTR of GIST

RecruitingNAAges 18 Years - 85 YearsAllAffiliated Hospital to Academy of Military Medica…
NCT07581977 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is designed to evaluate the efficacy and safety of a novel two-tooth endoscopic clip, utilized in a "clip with line" traction configuration, during endoscopic resection procedures (ESD and EFTR) of GIST. The novel clip's dual-tooth design is intended to provide a more secure anchor on the lesion, enabling effective counter-traction when combined with a line. The primary aim is to determine if this method improves submucosal dissection efficiency compared to conventional ESD. A secondary aim is to evaluate the performance of the same clip system for full-thickness or mucosal defect closure.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 and ≤ 85 years. * Patients diagnosed with gastric gastrointestinal lesions clinically indicated for ESD or EFTR. * Lesion size between 2 cm and 5 cm in diameter. * Willing and able to provide written informed consent. Exclusion Criteria: * Lesions with clear evidence of deep submucosal invasion or distant metastasis precluding curative endoscopic resection. * Severe coagulation dysfunction (international normalized ratio \>2.0, platelet count \<50,000/µL) or ongoing use of dual antiplatelet therapy/anticoagulants that cannot be appropriately bridged or discontinued per guidelines. * Severe organ failure (cardiac, renal, hepatic, or respiratory) rendering the patient unsuitable for prolonged sedation or general anesthesia. * Pregnancy or lactation. * Prior surgical or endoscopic intervention at the target lesion site that results in significant fibrosis.
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What it tests

  • A Novel Two-Tooth Endoscopic Clip
  • Clip
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Where

1 site
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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