Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:01 AM
Study NCT ID:
NCT07315893
Status:
RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D005773', 'term': 'Gastroscopy'}, {'id': 'D010147', 'term': 'Pain Measurement'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D009460', 'term': 'Neurologic Examination'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-04', 'studyFirstSubmitDate': '2025-12-21', 'studyFirstSubmitQcDate': '2025-12-21', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients with incomplete closure.', 'timeFrame': 'Up to 28 days', 'description': 'Percentage of patients with incomplete closure.'}, {'measure': 'Patients bleeding at closure site.', 'timeFrame': 'Up to 28 days', 'description': 'Percentage of patients bleeding at closure site within 28 days from procedure.'}, {'measure': 'Patients with infection at closure site.', 'timeFrame': 'Up to 28 days', 'description': 'Percentage of patients with infection at closure site within 28 days from procedure.'}, {'measure': 'Patients with leakage.', 'timeFrame': 'Up to 72 hours', 'description': 'Percentage of patients with leakage within 72 hours from procedure.'}, {'measure': 'Serious Adverse Device Effects (SADE)', 'timeFrame': 'Up to 28 days', 'description': 'Serious Adverse Device Effects (SADE) within 28 days from procedure.'}, {'measure': 'Overall rates of Adverse Device Effect', 'timeFrame': 'Up to 28 days', 'description': 'Overall rates of Adverse Device Effect within 28 days from procedure.'}], 'secondaryOutcomes': [{'measure': 'Overall rates of Serious Adverse Events', 'timeFrame': 'Up to 180 days', 'description': 'Overall rates of Serious Adverse Events will be recorded up to 180 days following the procedure.'}, {'measure': 'Serious Adverse Device Effects', 'timeFrame': 'Up to 90 days', 'description': 'Serious Adverse Device Effects (SADE) will be evaluated endoscopically at 2-14 and 90 days.'}, {'measure': 'Evidence of a Leak', 'timeFrame': 'Up to 30 days', 'description': 'Clinical, radiologic or endoscopic evidence of a Leak within 30 days'}, {'measure': 'Patient Quality of Life', 'timeFrame': 'Up to 180 days', 'description': 'Patient quality of life will be assessed by validated Health-Related Quality of Life Scale questionnaire.\n\nThe questionnaire includes several measures of perceived health status. The primary overall outcome is the Unhealthy Days Score, calculated as the sum of the number of days of poor physical health and poor mental health during the past 30 days. The score ranges from 0 to 30 days, with higher scores indicating worse health status and lower scores indicating better health status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopic mucosal resection (EMR)', 'endoscopic submucosal dissection (ESD)', 'a gastric neoplastic lesion'], 'conditions': ['Endoscopic Mucosal Resection', 'Endoscopic Submucosal Dissection (ESD)']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n1. Percentage of patients with incomplete closure.\n2. Percentage of patients bleeding at closure site within 28 days from procedure.\n3. Percentage of patients with infection at closure site within 28 days from procedure.\n4. Percentage of patients with leakage within 72 hours from procedure.\n5. Serious Adverse Device Effects (SADE) within 28 days from procedure.\n6. Overall rates of Adverse Device Effect within 28 days from procedure.\n\nStudy 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.\n\nThe 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.\n\nPostoperatively, 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.\n\nStudy follow-up visits will take place 4 weeks, 3 and 6 months post surgery.', 'detailedDescription': 'This study will be performed in accordance with the design and specific provisions of this protocol, in accordance with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP), Title 21 of the Code of Federal Regulations (21 CFR), part 812 (Investigational Device Exemptions), and the applicable regulatory requirements.\n\nThe study will be a prospective, single-center, open study, to evaluate the efficacy and safety of the Su2ura® GI System.\n\nThe study will be performed at the Tel Aviv Sourasky Medical Center, Israel. Up to 25 patients will be recruited to the study.\n\nFollowing 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.\n\nPostoperatively, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years\n2. Patient is able to provide informed consent .\n3. Body mass index (BMI) 20-40 kg/m2\n4. Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion\n5. Candidate for endoscopic defect closure based on the operating's endoscopist assessment.\n\nExclusion Criteria:\n\n1. Patient with severe comorbidities likely to limit survival to less than 2 years.\n2. Patients with INR\\>1.5\n3. Patients with PLT\\< 150\n4. Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) .\n5. Pregnant women or those intending to become pregnant during the study period\n6. Patient with ascites on physical examination or CT scan.\n7. Patient with varices.\n8. Patient on peritoneal dialysis.\n9. Patient with wound-healing disorders.\n10. Patient with significant coagulation disorders or those requiring anti thrombotic or anticoagulation treatment other than aspirin .\n11. Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily .\n12. Patients in need of immunomodulatory therapy.\n13. Immunocompromised patients (e.g., HIV/AIDS, organ transplant, chemo- or radiation therapy 6 months prior to recruitment).\n14. Patient in need of concomitant surgical procedures other than those permitted in the protocol.\n15. Non-compliance with the study protocol.\n16. Patient requests to exist the study. -"}, 'identificationModule': {'nctId': 'NCT07315893', 'briefTitle': 'Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System', 'organization': {'class': 'OTHER', 'fullName': 'Anchora Medical'}, 'officialTitle': 'Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System', 'orgStudyIdInfo': {'id': 'ANC-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Su2ura® GI System-study device group', 'description': 'All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure.', 'interventionNames': ['Device: Su2ura® GI system', 'Diagnostic Test: Physical Examination', 'Diagnostic Test: Vital Signs', 'Diagnostic Test: Blood Test-Hematology', 'Diagnostic Test: Blood Test-Biochemistry', 'Diagnostic Test: Urine Pregnancy Test', 'Diagnostic Test: Gastroscopy', 'Diagnostic Test: Health-related quality of life (HR-QoL)', 'Diagnostic Test: Visual Analogue Scale (VAS)']}], 'interventions': [{'name': 'Su2ura® GI system', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Su2ura® GI System-study device group']}, {'name': 'Physical Examination', 'type': 'DIAGNOSTIC_TEST', 'description': "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.", 'armGroupLabels': ['Su2ura® GI System-study device group']}, {'name': 'Vital Signs', 'type': 'DIAGNOSTIC_TEST', 'description': 'Vital signs include blood pressure, pulse, temperature, body weight and height, BMI.', 'armGroupLabels': ['Su2ura® GI System-study device group']}, {'name': 'Blood Test-Hematology', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Su2ura® GI System-study device group']}, {'name': 'Blood Test-Biochemistry', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Su2ura® GI System-study device group']}, {'name': 'Urine Pregnancy Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Women with child-bearing potential will undergo a urine pregnancy test during the screening visit.', 'armGroupLabels': ['Su2ura® GI System-study device group']}, {'name': 'Gastroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': "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.", 'armGroupLabels': ['Su2ura® GI System-study device group']}, {'name': 'Health-related quality of life (HR-QoL)', 'type': 'DIAGNOSTIC_TEST', 'description': 'A questionnaire assessing patient-reported satisfaction and function.', 'armGroupLabels': ['Su2ura® GI System-study device group']}, {'name': 'Visual Analogue Scale (VAS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'A validated, subjective measure measuring acute and chronic pain.', 'armGroupLabels': ['Su2ura® GI System-study device group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Iddo Bar-Yishay, MD', 'role': 'CONTACT', 'email': 'iddob@tlvmc.gov.il', 'phone': '+972-51-5617202'}], 'facility': 'Tel-Aviv Sourasky Medical Center, Ichilov', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Nadya Lisovoder, MD', 'role': 'CONTACT', 'email': 'nadyal@galilee-cbr.com', 'phone': '+972-52-4753435'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anchora Medical', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}