Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
NCT ID: NCT07315893
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-08-18
2026-12-31
Brief Summary
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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.
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Detailed Description
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The study will be a prospective, single-center, open study, to evaluate the efficacy and safety of the Su2ura® GI System.
The study will be performed at the Tel Aviv Sourasky Medical Center, Israel. Up to 25 patients will be recruited to the study.
Following resection of the lesion using either endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), the procedure involves endoscopic insertion of the Su2ura® GI system through the gastroscope working channel, followed by tissue grasping and approximation using sequential deployment of T-Tag Anchors in a predefined suturing pattern. Full-thickness anchors are placed in a controlled manner to achieve safe and effective tissue approximation, after which the suture is secured using the Su2ura® Knot device.
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Su2ura® GI System-study device group
All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure.
Su2ura® GI system
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.
Physical Examination
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
Vital signs include blood pressure, pulse, temperature, body weight and height, BMI.
Blood Test-Hematology
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.
Blood Test-Biochemistry
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.
Urine Pregnancy Test
Women with child-bearing potential will undergo a urine pregnancy test during the screening visit.
Gastroscopy
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.
Health-related quality of life (HR-QoL)
A questionnaire assessing patient-reported satisfaction and function.
Visual Analogue Scale (VAS)
A validated, subjective measure measuring acute and chronic pain.
Interventions
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Su2ura® GI system
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.
Physical Examination
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
Vital signs include blood pressure, pulse, temperature, body weight and height, BMI.
Blood Test-Hematology
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.
Blood Test-Biochemistry
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.
Urine Pregnancy Test
Women with child-bearing potential will undergo a urine pregnancy test during the screening visit.
Gastroscopy
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.
Health-related quality of life (HR-QoL)
A questionnaire assessing patient-reported satisfaction and function.
Visual Analogue Scale (VAS)
A validated, subjective measure measuring acute and chronic pain.
Eligibility Criteria
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Inclusion Criteria
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
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. -
18 Years
ALL
No
Sponsors
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Anchora Medical
OTHER
Responsible Party
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Locations
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Tel-Aviv Sourasky Medical Center, Ichilov
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANC-201
Identifier Type: -
Identifier Source: org_study_id
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