Full-thickness endoscopic suturing to close stomach lining defects using the Su2ura® GI system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, open-label study at Tel-Aviv Sourasky Medical Center enrolling up to 25 adults referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions. After lesion removal, the Su2ura® GI system is inserted through the gastroscope, T-Tag anchors are deployed in a predefined pattern to achieve full-thickness tissue approximation, and the suture is secured with the Su2ura® Knot device. The study focuses on safety endpoints including incomplete closure, bleeding, infection, leakage, and device-related adverse events with follow-up visits at discharge, 4 weeks, 3 months, and 6 months. Total participation lasts up to about 6.5 months per patient.

Why it matters

Who can join: the full rules

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. -

Where it's running

• Tel-Aviv Sourasky Medical Center, Ichilov
  Tel Aviv, Israel Recruiting

Study contacts

• Study coordinator: Nadya Lisovoder, MD
• Email: nadyal@galilee-cbr.com
• Phone: +972-52-4753435

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.