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A Novel Two-Tooth Clip for ESD and EFTR of GIST: A Prospective RCT
Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
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.
Official title: Efficacy and Safety of a Novel Two-Tooth Clip-Assisted ESD and EFTR of GIST: A Single-Center, Prospective, Open-Label, Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04-24
Completion Date
2027-07-01
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
A Novel Two-Tooth Endoscopic Clip
"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.
Clip
Standard ESD or EFTR without the use of dedicated traction devices will be performed, then using the standard clips for closure.
Locations (1)
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, China