NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST
| NCT ID | NCT07581977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Affiliated Hospital to Academy of Military Medical Sciences |
| Condition | GIST - Gastrointestinal Stromal Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-24 |
| Primary Completion | 2027-04-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-04-24 with a primary completion date of 2027-04-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Yan Liu, M.D.,Ph.D.
PRINCIPAL INVESTIGATOR
Beijing 302 Hospital
Frequently Asked Questions
Who can join the NCT07581977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying GIST - Gastrointestinal Stromal Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07581977 currently recruiting?
Yes, NCT07581977 is actively recruiting participants. Contact the research team at minmin823@sina.com for enrollment information.
Where is the NCT07581977 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07581977 clinical trial?
NCT07581977 is sponsored by Affiliated Hospital to Academy of Military Medical Sciences. The principal investigator is Yan Liu, M.D.,Ph.D. at Beijing 302 Hospital. The trial plans to enroll 60 participants.