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

Официальное название

A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue: a Prospective, Multicenter, Randomized Controlled Clinical Trial

Обзор

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.

Вмешательства

• Устройство disposable endoscopic closing device
  Using disposable endoscopic closing device to closure and hemostasis
• Устройство 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

Первичные конечные точки

• Effectiveness : composite clinical success rate. Composite clinical success = Technical success AND 7-day post-procedural clinical success AND 30-day post-procedural clinical success. [Срок оценки: 30 days]

Вторичные конечные точки (4)

• Endoscopic procedure time. [Срок оценки: 2 hours]
• Adverse Event Rate [Срок оценки: 30 days]
• Serious Adverse Event Rate [Срок оценки: 30 days]
• Device Malfunction Rate [Срок оценки: 2 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07727564 · VDKPF-HCD-046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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