Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
Anchora Medical
25 participants
Aug 18, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
The Su2ura® GI handle is used to control tissue grasping, anchor deployment, and suture placement, enabling controlled full-thickness tissue approximation through sequential deployment of T-Tag Anchors in a predefined suturing pattern.
The patient will undergo a standard physical examination by an authorized physician. The physician's evaluation will include diagnosis and documentation of any significant clinical abnormalities or diseases.
Vital signs include blood pressure, pulse, temperature, body weight and height, BMI.
All subjects will undergo Hematology blood tests. Blood Hematology and Biochemistry will include standard of care measurements. 5 ml of blood (equals to 1 spoon) will be taken for each test.
All subjects will undergo Biochemistry blood tests. Blood Hematology and Biochemistry will include standard of care measurements. 5 ml of blood (equals to 1 spoon) will be taken for each test.
Women with child-bearing potential will undergo a urine pregnancy test during the screening visit.
During visit 4 (Day 28 ± 2 days after procedure) a gastroscopy examination will be performed, to negate local recurrence. The examination will be performed as accepted, with a gastroscope with an NBI/BLI optical filter. Biopsies will be sampled as needed, at a gastroenterologist's discretion.
A questionnaire assessing patient-reported satisfaction and function.
A validated, subjective measure measuring acute and chronic pain.
Locations(1)
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NCT07315893