A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue: a Prospective, Multicenter, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Effectiveness : composite clinical success rate. Composite clinical success = Technical success AND 7-day post-procedural clinical success AND 30-day post-procedural clinical success.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No restrictions on gender or race.
- •Intraoperative endoscopic confirmation of gastrointestinal tissue defects or lesions (≤50 mm) requiring closure, such as post-endoscopic resection mucosal defects, gastrointestinal fistulas, active bleeding, gastrointestinal perforation, colonic diverticular bleeding, etc.
- •The local anatomy, tissue thickness, and inflammatory status of the target lesion and its surrounding tissues are assessed by the endoscopist as sufficient to withstand the mechanical tensile and anchoring forces exerted by the device (screws or clips).
- •Patients possess good communication skills and compliance, are willing to cooperate in completing a 30-day clinical follow-up observation, and have an expected survival of more than 6 months.
- •Voluntary participation in this clinical trial, with written informed consent approved by the Ethics Committee signed by the patient or their legally authorized representative.
排除标准
- •Presence of severe coagulation disorders, specifically defined as: platelet count < 50 × 10⁹/L, or international normalized ratio (INR) > 2.0, or partial thromboplastin time (PTT) > 2× the upper limit of normal, and not correctable by blood product transfusion or medication prior to the procedure.
- •Concomitant high-risk conditions such as severe organ dysfunction, including: severe hepatic or renal insufficiency (AST or ALT > 3× upper limit of normal; serum creatinine > 3× upper limit of normal), heart failure classified as NYHA Class III-IV, or presence of impaired consciousness, or profound hemorrhagic shock (systolic blood pressure < 90 mmHg and heart rate > 110 bpm) without successful resuscitation.
- •Continuous use of systemic anticoagulants (e.g., warfarin, novel oral anticoagulants) or dual antiplatelet agents within 7 days prior to the procedure (with the exception of aspirin monotherapy), and inability to safely discontinue or implement bridging therapy before and after the procedure.
- •Known allergy to medical-grade surgical stainless steel (containing metallic components such as nickel, cobalt, chromium), polypropylene polymeric materials, or anesthetic/sedative medications required for endoscopic procedures.
- •Female patients who are pregnant or breastfeeding.
- •Current participation in another drug or medical device clinical trial, with less than 30 days having elapsed since the last withdrawal from the previous trial, or presence of any other factors that, in the investigator's opinion, may interfere with the evaluation of trial outcomes.
- •Conditions deemed by the investigator as inappropriate for the patient's enrollment.
结局指标
主要结局
Effectiveness : composite clinical success rate. Composite clinical success = Technical success AND 7-day post-procedural clinical success AND 30-day post-procedural clinical success.
时间窗: 30 days
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
次要结局
- Endoscopic procedure time.(2 hours)
- Adverse Event Rate(30 days)
- Serious Adverse Event Rate(30 days)
- Device Malfunction Rate(2 hours)