Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07581977

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

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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