A Novel Two-Tooth Clip for ESD and EFTR of GIST: A Prospective RCT
Efficacy and Safety of a Novel Two-Tooth Clip-Assisted ESD and EFTR of GIST: A Single-Center, Prospective, Open-Label, Randomized Controlled Study
Affiliated Hospital to Academy of Military Medical Sciences
60 participants
Apr 24, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria4
- 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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Interventions
"Clip with line" traction method with the novel two-tooth clip will be applied in patients undergoing ESD or EFTR. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips.
Standard ESD or EFTR without the use of dedicated traction devices will be performed, then using the standard clips for closure.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07581977