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Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System

RecruitingNAAges 18 Years - anyAllAnchora Medical
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In plain words

What the trial is, and whether it could suit you

The objective of this clinical study is to assess the safety of the Su2ura® GI system when used for endoscopic suturing and soft-tissue approximation in patients referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions. The main questions it aims to answer are: 1. Percentage of patients with incomplete closure. 2. Percentage of patients bleeding at closure site within 28 days from procedure. 3. Percentage of patients with infection at closure site within 28 days from procedure. 4. Percentage of patients with leakage within 72 hours from procedure. 5. Serious Adverse Device Effects (SADE) within 28 days from procedure. 6. Overall rates of Adverse Device Effect within 28 days from procedure. Study includes 6 visits: Screening, Baseline/Surgery, Discharge and 4 weeks, 3 months and 6 months post-surgery. The actual point of en

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥18 years 2. Patient is able to provide informed consent . 3. Body mass index (BMI) 20-40 kg/m2 4. Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion 5. Candidate for endoscopic defect closure based on the operating's endoscopist assessment. Exclusion Criteria: 1. Patient with severe comorbidities likely to limit survival to less than 2 years. 2. Patients with INR\>1.5 3. Patients with PLT\< 150 4. Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) . 5. Pregnant women or those intending to become pregnant during the study period 6. Patient with ascites on physical examination or CT scan. 7. Patient with varices. 8. Patient on peritoneal dialysis. 9. Patient with wound-healing disorders. 10. Patient with significant coagulation disorders or those requiring anti thrombotic or anticoagulation treatment other than aspirin . 11. Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily . 12. Patients in need of immunomodulatory therapy. 13. Immunocompromised patients (e.g., HIV/AIDS, organ transplant, chemo- or radiation therapy 6 months prior to recruitment). 14. Patient in need of concomitant surgical procedures other than those permitted in the protocol. 15. Non-compliance with the study protocol. 16. Patient requests to exist the study. -
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What it tests

  • Su2ura® GI system
  • Physical Examination
  • Vital Signs
  • Blood Test-Hematology
  • Blood Test-Biochemistry
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Where

1 site
Tel-Aviv Sourasky Medical Center, Ichilov
Tel Aviv, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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