Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System

Обзор

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.

Подробное описание

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.

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.

Вмешательства

• Устройство 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.
• Диагностический тест 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.
• Диагностический тест Vital Signs
  Vital signs include blood pressure, pulse, temperature, body weight and height, BMI.
• Диагностический тест 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.
• Диагностический тест 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.
• Диагностический тест Urine Pregnancy Test
  Women with child-bearing potential will undergo a urine pregnancy test during the screening visit.
• Диагностический тест 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.
• Диагностический тест Health-related quality of life (HR-QoL)
  A questionnaire assessing patient-reported satisfaction and function.
• Диагностический тест Visual Analogue Scale (VAS)
  A validated, subjective measure measuring acute and chronic pain.

Первичные конечные точки

• Patients with incomplete closure. [Срок оценки: Up to 28 days]
• Patients bleeding at closure site. [Срок оценки: Up to 28 days]
• Patients with infection at closure site. [Срок оценки: Up to 28 days]
• Patients with leakage. [Срок оценки: Up to 72 hours]
• Serious Adverse Device Effects (SADE) [Срок оценки: Up to 28 days]
• Overall rates of Adverse Device Effect [Срок оценки: Up to 28 days]

Вторичные конечные точки (4)

• Overall rates of Serious Adverse Events [Срок оценки: Up to 180 days]
• Serious Adverse Device Effects [Срок оценки: Up to 90 days]
• Evidence of a Leak [Срок оценки: Up to 30 days]
• Patient Quality of Life [Срок оценки: Up to 180 days]

Критерии участия

Критерии включения

• Age ≥18 years
• Patient is able to provide informed consent .
• Body mass index (BMI) 20-40 kg/m2
• Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion
• Candidate for endoscopic defect closure based on the operating's endoscopist assessment.

Критерии исключения

• Patient with severe comorbidities likely to limit survival to less than 2 years.
• Patients with INR>1.5
• Patients with PLT< 150
• Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) .
• Pregnant women or those intending to become pregnant during the study period
• Patient with ascites on physical examination or CT scan.
• Patient with varices.
• Patient on peritoneal dialysis.
• Patient with wound-healing disorders.
• Patient with significant coagulation disorders or those requiring anti thrombotic or anticoagulation treatment other than aspirin .
• Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily .
• Patients in need of immunomodulatory therapy.
• Immunocompromised patients (e.g., HIV/AIDS, organ transplant, chemo- or radiation therapy 6 months prior to recruitment).
• Patient in need of concomitant surgical procedures other than those permitted in the protocol.
• Non-compliance with the study protocol.
• Patient requests to exist the study. -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Tel-Aviv Sourasky Medical Center, Ichilov — Tel Aviv

Идентификаторы

NCT: NCT07315893 · ANC-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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