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

NCT07315893 | Recruiting

• 1 other identifier: ANC-201
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 1.Percentage of patients with incomplete closure.
2. 2.Percentage of patients bleeding at closure site within 28 days from procedure.
3. 3.Percentage of patients with infection at closure site within 28 days from procedure.
4. 4.Percentage of patients with leakage within 72 hours from procedure.
5. 5.Serious Adverse Device Effects (SADE) within 28 days from procedure.
6. 6.Overall rates of Adverse Device Effect within 28 days from procedure.

Conditions

Endoscopic Mucosal Resection; Endoscopic Submucosal Dissection (ESD)

Keywords

endoscopic mucosal resection (EMR); endoscopic submucosal dissection (ESD); a gastric neoplastic lesion

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Overall rates of Serious Adverse Events

  Up to 180 days

• Serious Adverse Device Effects

  Up to 90 days

• Evidence of a Leak

  Up to 30 days

• Patient Quality of Life

  Up to 180 days

Study Arms (1)

Su2ura® GI System-study device group

EXPERIMENTAL

All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure.

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

Su2ura® GI system DEVICE

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.

Su2ura® GI System-study device group

Physical Examination DIAGNOSTIC_TEST

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.

Su2ura® GI System-study device group

Vital Signs DIAGNOSTIC_TEST

Vital signs include blood pressure, pulse, temperature, body weight and height, BMI.

Su2ura® GI System-study device group

Blood Test-Hematology DIAGNOSTIC_TEST

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.

Su2ura® GI System-study device group

Blood Test-Biochemistry DIAGNOSTIC_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.

Su2ura® GI System-study device group

Urine Pregnancy Test DIAGNOSTIC_TEST

Women with child-bearing potential will undergo a urine pregnancy test during the screening visit.

Su2ura® GI System-study device group

Gastroscopy DIAGNOSTIC_TEST

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.

Su2ura® GI System-study device group

Health-related quality of life (HR-QoL) DIAGNOSTIC_TEST

A questionnaire assessing patient-reported satisfaction and function.

Su2ura® GI System-study device group

Visual Analogue Scale (VAS) DIAGNOSTIC_TEST

A validated, subjective measure measuring acute and chronic pain.

Su2ura® GI System-study device group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anchora Medical: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center, Ichilov

Tel Aviv, Israel

RECRUITING

MeSH Terms

Interventions

Physical Examination; Vital Signs; Gastroscopy; Pain Measurement

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Neurologic Examination

Central Study Contacts

Nadya Lisovoder, MD

CONTACT

+972-52-4753435; nadyal@galilee-cbr.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure.

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 5, 2026
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

IL (1)