Actively Recruiting
A Novel Two-Tooth Clip for ESD and EFTR of GIST: A Prospective RCT
Led by Affiliated Hospital to Academy of Military Medical Sciences · Updated on 2026-05-12
60
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Novel Two-Tooth Clip for ESD and EFTR of GIST: A Prospective RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years
- Diagnosed with gastric gastrointestinal lesions needing ESD or EFTR
- Lesion size between 2 cm and 5 cm in diameter
- Willing and able to provide written informed consent
You will not qualify if you...
- Lesions with deep submucosal invasion or distant metastasis preventing curative endoscopic resection
- Severe coagulation problems (INR > 2.0, platelet count < 50,000/µL) or use of dual antiplatelet therapy/anticoagulants that cannot be safely managed
- Severe organ failure (heart, kidney, liver, or lungs) making sedation or anesthesia unsuitable
- Pregnancy or breastfeeding
- Previous surgery or endoscopic treatment at the lesion site causing significant fibrosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, China, 100071
Actively Recruiting
Research Team
M
Min Min, M.D., Ph.D.
CONTACT
Y
Yan Liu, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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