Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips
NCT06285955 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10
Last updated 2024-08-23
Summary
Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate.
Conditions
- Pilot Study
- Clips
Sponsors & Collaborators
-
Beijing 302 Hospital
lead OTHER
Principal Investigators
-
Yan Liu, MD · The Fifth Medical Center of Chinese PLA General Hosptial
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-15
- Primary Completion
- 2024-06-30
- Completion
- 2024-07-31
Countries
- China
Study Locations
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