Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection (ESD)
Conditions
Keywords
endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), a gastric neoplastic lesion
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. 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.
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.
Interventions
DEVICESu2ura® 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_TESTPhysical 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_TESTVital Signs
Vital signs include blood pressure, pulse, temperature, body weight and height, BMI.
DIAGNOSTIC_TESTBlood 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_TESTBlood 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_TESTUrine Pregnancy Test
Women with child-bearing potential will undergo a urine pregnancy test during the screening visit.
DIAGNOSTIC_TESTGastroscopy
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_TESTHealth-related quality of life (HR-QoL)
A questionnaire assessing patient-reported satisfaction and function.
DIAGNOSTIC_TESTVisual Analogue Scale (VAS)
A validated, subjective measure measuring acute and chronic pain.
Sponsors
Anchora Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall rates of Adverse Device Effect | Up to 28 days | Overall rates of Adverse Device Effect within 28 days from procedure. |
| Patients bleeding at closure site. | Up to 28 days | Percentage of patients bleeding at closure site within 28 days from procedure. |
| Patients with infection at closure site. | Up to 28 days | Percentage of patients with infection at closure site within 28 days from procedure. |
| Patients with leakage. | Up to 72 hours | Percentage of patients with leakage within 72 hours from procedure. |
| Serious Adverse Device Effects (SADE) | Up to 28 days | Serious Adverse Device Effects (SADE) within 28 days from procedure. |
| Patients with incomplete closure. | Up to 28 days | Percentage of patients with incomplete closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Device Effects | Up to 90 days | Serious Adverse Device Effects (SADE) will be evaluated endoscopically at 2-14 and 90 days. |
| Evidence of a Leak | Up to 30 days | Clinical, radiologic or endoscopic evidence of a Leak within 30 days |
| Patient Quality of Life | Up to 180 days | 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. |
| Overall rates of Serious Adverse Events | Up to 180 days | Overall rates of Serious Adverse Events will be recorded up to 180 days following the procedure. |
Countries
Israel
Contacts
Primary ContactNadya Lisovoder, MD
Outcome results
None listed