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NOT YET RECRUITING
NCT07727564
NA

A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue

Sponsor: Jiangsu Vedkang Medical Science and Technology Co., Ltd

View on ClinicalTrials.gov

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

DEVICE

disposable endoscopic closing device

Using disposable endoscopic closing device to closure and hemostasis

DEVICE

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