Actively Recruiting
Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
Led by Anchora Medical · Updated on 2026-01-07
25
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to provide informed consent
- Body mass index (BMI) between 20 and 40 kg/m2
- Referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion
- Candidate for endoscopic defect closure as assessed by the operating endoscopist
You will not qualify if you...
- Severe comorbidities expected to limit survival to less than 2 years
- INR greater than 1.5
- Platelet count less than 150
- Known collagen or connective tissue disorders (e.g., scleroderma, Marfan syndrome)
- Pregnant women or planning pregnancy during the study
- Presence of ascites on physical exam or CT scan
- Presence of varices
- On peritoneal dialysis
- Wound-healing disorders
- Significant coagulation disorders or need for antithrombotic/anticoagulation therapy other than aspirin
- Autoimmune disorder requiring more than 10 mg corticosteroids daily
- Need for immunomodulatory therapy
- Immunocompromised status (e.g., HIV/AIDS, organ transplant, recent chemo- or radiation therapy within 6 months)
- Need for other surgical procedures not allowed by the protocol
- Non-compliance with study protocol
- Request to exit the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tel-Aviv Sourasky Medical Center, Ichilov
Tel Aviv, Israel
Actively Recruiting
Research Team
N
Nadya Lisovoder, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here