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

Korábbi kezelés

• 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.
• 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.

Más betegség

• 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.
• Conditions deemed by the investigator as inappropriate for the patient's enrollment.

Laborértékek

• 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.

Egyéb

• Female patients who are pregnant or breastfeeding.

• 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.