A Novel Two-Tooth Clip for ESD and EFTR of GIST

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Submucosal Dissection Efficiency — 24 hours
  The rate of submucosal dissection (measured in mm²/min), calculated from the start of submucosal entry to the completion of lesion removal.

Trial sites (1)

More Affiliated Hospital to Academy of Military Medical Sciences trials in China

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