Actively Recruiting
Endoscopic Full Thickness Suturing of Mucosal, Submucosal, and Perforation Defects Using Su2ura4 GI System
Led by Anchora Medical · Updated on 2026-01-07
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of the Su2ura4 GI system for endoscopic suturing and soft-tissue closure in patients undergoing endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions. This prospective, open-label study aims to measure rates of incomplete closure, bleeding, infection, leakage, and adverse device effects within specific timeframes after the procedure. Up to 25 patients will be recruited for this single-center study. Participants will undergo tissue resection by EMR or ESD, followed immediately by endoscopic suturing using the Su2ura4 GI system. The device is inserted through the gastroscope to grasp tissue and deploy full-thickness anchors in a controlled pattern, securing the suture with a knot device. The procedure is followed by a typical recovery with an expected one-night hospital stay and discharge the next day. The study includes six visits: screening, baseline/surgery day, discharge with 4-week, 3-month, and 6-month post-surgery follow-ups. During the study, patients will have physical exams, vital sign checks, blood tests, and quality of life questionnaires at regular intervals. A gastroscopy will be performed around 28 days post-procedure to check for local recurrence. Researchers will closely monitor safety outcomes including adverse device effects and serious events up to 6 months. Total participation time for each patient is up to about 6.5 months, with careful observation throughout the recovery and follow-up periods.
CONDITIONS
Brief 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 likely to limit survival to less than 2 years
- International Normalized Ratio (INR) greater than 1.5
- Platelet count less than 150
- Known collagen or connective tissue disorders (e.g., scleroderma, Marfan syndrome)
- Pregnant women or those intending to become pregnant during the study period
- Ascites detected on physical exam or CT scan
- Presence of varices
- Patients on peritoneal dialysis
- Wound-healing disorders
- Significant coagulation disorders or requiring antithrombotic or anticoagulation treatment other than aspirin
- Autoimmune disorder requiring more than 10 mg of corticosteroids daily
- Need for immunomodulatory therapy
- Immunocompromised status (e.g., HIV/AIDS, organ transplant, chemotherapy or radiation within 6 months prior)
- Need for concomitant surgical procedures not permitted by the protocol
- Non-compliance with study protocol
- Patient requests to exit the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo endoscopic full thickness suturing of mucosal, submucosal, and perforation defects using the Su2ura® GI System following endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD).
1 procedure visit (in-person)
Duration - Up to 2 days
After the procedure, participants are transferred to the recovery area and then to the surgical ward for standard monitoring, including an expected one-night postoperative hospital stay.
Hospital stay for approximately 1 night
Duration - Up to 28 days
Participants are monitored for safety and efficacy outcomes including assessment of closure site healing, bleeding, infection, leakage, and adverse device effects.
1 follow-up visit around Day 28 (± 2 days) including gastroscopy and biopsies as needed
Duration - Up to 180 days
Participants are followed for longer-term safety and quality of life outcomes after the procedure.
Periodic assessments including quality of life questionnaires and safety monitoring
Trial Site Locations
Total: 1 location
1
Tel-Aviv Sourasky Medical Center, Ichilov
Tel Aviv, Israel
Actively Recruiting
Research Team
N
Nadya Lisovoder, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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