A Novel Two-Tooth Clip for ESD and EFTR of GIST
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 ef
| Condition(s) | GIST - Gastrointestinal Stromal Tumor |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 sur |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Affiliated Hospital to Academy of Military Medical Sciences |
| Locations | Beijing, China |
| Start date | 2026-04-24 |
| NCT ID | NCT07581977 |
| Official listing | https://clinicaltrials.gov/study/NCT07581977 |