A Novel Two-Tooth Clip for ESD and EFTR of GIST
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAffiliated Hospital to Academy of Military Medical Sciences
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- A Novel Two-Tooth Endoscopic Clip
- Clip
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov