Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
Recruiting now · Not applicable
Conditions studied: Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection (ESD)
In brief
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 enrollment for each subject is considered the day of surgery. Total study duration is up to 6.5 months. The patient will be admitted to the medical center on the day of the procedure or one day prior for preoperative preparation. Following tissue resection using one of the methods (ESD or EMR), suturing will be performed using the Su2ura® GI system. Postoperatively, the patient will be transferred to the recovery area and then to the surgical ward for standard monitoring, with an expected one-night postoperative stay and discharge the following day. Study follow-up visits will take place 4 weeks, 3 and 6 months post surgery.
Key facts
- Study ID
- NCT07315893
- Run by
- Anchora Medical
- People needed
- 25
- Starts
- 2025-08-18
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Patient is able to provide informed consent .
- Body mass index (BMI) 20-40 kg/m2
- Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion
- Candidate for endoscopic defect closure based on the operating's endoscopist assessment.
You may not qualify if…
- Patient with severe comorbidities likely to limit survival to less than 2 years.
- Patients with INR>1.5
- Patients with PLT< 150
- Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) .
- Pregnant women or those intending to become pregnant during the study period
- Patient with ascites on physical examination or CT scan.
- Patient with varices.
- Patient on peritoneal dialysis.
- Patient with wound-healing disorders.
- Patient with significant coagulation disorders or those requiring anti thrombotic or anticoagulation treatment other than aspirin .
- Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily .
- Patients in need of immunomodulatory therapy.
- Immunocompromised patients (e.g., HIV/AIDS, organ transplant, chemo- or radiation therapy 6 months prior to recruitment).
- Patient in need of concomitant surgical procedures other than those permitted in the protocol.
- Non-compliance with the study protocol.
- Patient requests to exist the study. -
Where it is running
- Tel-Aviv Sourasky Medical Center, Ichilov — Tel Aviv, Israel (enrolling)
Full record on ClinicalTrials.gov
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