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A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue
Sponsor: Jiangsu Vedkang Medical Science and Technology Co., Ltd
Summary
This clinical trial employs a prospective, multicenter, randomized, single-blind, parallel-controlled, non-inferiority design with a positive comparator device. The study aims to assess the safety and efficacy of the disposable endoscopic closing device manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd. when applied for gastrointestinal tissue closing and hemostasis. The trial group will undergo closure and hemostasis using disposable endoscopic closing device. The control group will undergo closure and hemostasis using metal clips, or metal clips in combination with nylon loops. This device is clinically indicated for patients requiring closure of gastrointestinal tissue. Primary effectiveness endpoint: composite clinical success rate. Secondary effectiveness endpoints: endoscopic procedure time. Secondary safety endpoints: incidence of adverse events, incidence of serious adverse events, and incidence of device malfunctions. Vital signs and hemoglobin changes will be closely monitored during the 24-hour period following the procedure. At 7 days postoperatively, a follow-up assessment (either outpatient or by telephone) will be performed. At 30 days postoperatively, the final outpatient follow-up visit will be conducted.
Official title: A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue: a Prospective, Multicenter, Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-07-31
Completion Date
2027-07-30
Last Updated
2026-07-27
Healthy Volunteers
No
Interventions
disposable endoscopic closing device
Using disposable endoscopic closing device to closure and hemostasis
metal clips, or metal clips in combination with nylon loops
Using metal clips, or metal clips in combination with nylon loops to closure and hemostasis