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

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.

Study Overview

• Status: Recruiting
• Conditions: Endoscopic Mucosal Resection; Endoscopic Submucosal Dissection (ESD)
• Intervention / Treatment: 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)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadya Lisovoder, MD; Phone Number: +972-52-4753435; Email: nadyal@galilee-cbr.com

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel-Aviv Sourasky Medical Center, Ichilov
    • Contact: Iddo Bar-Yishay, MD; Phone Number: +972-51-5617202; Email: iddob@tlvmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years
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:

1. Patient with severe comorbidities likely to limit survival to less than 2 years.
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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Su2ura® GI System-study device group; All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients with incomplete closure.	Percentage of patients with incomplete closure.	Up to 28 days
Patients bleeding at closure site.	Percentage of patients bleeding at closure site within 28 days from procedure.	Up to 28 days
Patients with infection at closure site.	Percentage of patients with infection at closure site within 28 days from procedure.	Up to 28 days
Patients with leakage.	Percentage of patients with leakage within 72 hours from procedure.	Up to 72 hours
Serious Adverse Device Effects (SADE)	Serious Adverse Device Effects (SADE) within 28 days from procedure.	Up to 28 days
Overall rates of Adverse Device Effect	Overall rates of Adverse Device Effect within 28 days from procedure.	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall rates of Serious Adverse Events	Overall rates of Serious Adverse Events will be recorded up to 180 days following the procedure.	Up to 180 days
Serious Adverse Device Effects	Serious Adverse Device Effects (SADE) will be evaluated endoscopically at 2-14 and 90 days.	Up to 90 days
Evidence of a Leak	Clinical, radiologic or endoscopic evidence of a Leak within 30 days	Up to 30 days
Patient Quality of Life	Patient quality of life will be assessed by validated Health-Related Quality of Life Scale questionnaire. The 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.	Up to 180 days

Collaborators and Investigators

• Sponsor: Anchora Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Estimated): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: endoscopic submucosal dissection (ESD); endoscopic mucosal resection (EMR); a gastric neoplastic lesion
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Neurologic Examination; Gastroscopy; Physical Examination; Vital Signs; Pain Measurement
• Other Study ID Numbers: ANC-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No