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.
Inclusion Criteria:
Exclusion Criteria:
hongjun.shao@vedkang.com+86 15161150617
Purse String Suture Device vs. Endoclip for Immediate Endoscopic Procedure Associated Gastrointestinal Perforation
EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection
Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips
Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture
ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding