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

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

This will test whether the Su2ura® GI device can safely close stomach tissue after EMR or ESD in adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Anchora Medical (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Tel Aviv)
• Trial ID: NCT07315893 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with BMI 20–40 who are referred for EMR or ESD of a gastric neoplastic lesion and judged by the endoscopist to be candidates for endoscopic defect closure are ideal candidates.

Not a fit: Patients with significant coagulation problems, low platelets or high INR, connective tissue disorders, ascites, varices, those on required anticoagulation (other than aspirin), pregnant patients, or those with limited life expectancy are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the device could provide more reliable full-thickness closure after EMR/ESD and reduce leakage, bleeding, and infection at resection sites.

How similar studies have performed: Other endoscopic full-thickness closure and anchoring devices have shown promise for closing GI defects, but the Su2ura® system itself is relatively new with limited published clinical data.

Eligibility criteria

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 this trial is running

Tel Aviv

• Tel-Aviv Sourasky Medical Center, Ichilov — Tel Aviv, Israel (Recruiting)

Study contacts

• Study coordinator: Nadya Lisovoder, MD

Conditions Endoscopic Mucosal Resection; Endoscopic Submucosal Dissection; endoscopic mucosal resection; endoscopic submucosal dissection; a gastric neoplastic lesion