A Novel Two-Tooth Clip for ESD and EFTR of GIST
Recruiting now · Not applicable
Conditions studied: GIST - Gastrointestinal Stromal Tumor
In brief
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.
Key facts
- Study ID
- NCT07581977
- Run by
- Affiliated Hospital to Academy of Military Medical Sciences
- People needed
- 60
- Starts
- 2026-04-24
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Fifth Medical Center of Chinese PLA General Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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