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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Using disposable endoscopic closing device to closure and hemostasis
Using metal clips, or metal clips in combination with nylon loops to closure and hemostasis
Effectiveness : composite clinical success rate. Composite clinical success = Technical success AND 7-day post-procedural clinical success AND 30-day post-procedural clinical success.
Technical success is defined as the successful achievement of complete closure of the target lesion or immediate hemostasis following a single application of the randomly assigned investigational or control device during the initial endoscopic procedure, without the need for any unassigned adjunctive closure devices not originally allocated. 7-day post-procedural clinical successis defined as the absence of any clinically significant delayed bleeding event occurring from the completion of the initial endoscopic procedure up to post-operative day 7 (±1 day). 30-day post-procedural clinical success is defined as the patient concurrently meeting all of the following criteria from the completion of the initial endoscopic procedure up to post-operative day 30 (±3 days): 1. Absence of clinically significant delayed bleeding 2. Absence of perforation 3. Absence of salvage interventions 4. Absence of attributable mortality
Time frame: 30 days
Endoscopic procedure time.
Time frame: 2 hours
Adverse Event Rate
Time frame: 30 days
Serious Adverse Event Rate
Time frame: 30 days
Device Malfunction Rate
Time frame: 2 hours
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