Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnchora Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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) .
Trial design
Design model
Single group
Treatments tested in this trial
Su2ura® GI system
DeviceThe 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.
Physical Examination
Diagnostic testThe 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.
Vital Signs
Diagnostic testVital signs include blood pressure, pulse, temperature, body weight and height, BMI.
Blood Test-Hematology
Diagnostic testAll 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.
Blood Test-Biochemistry
Diagnostic testAll 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.
Urine Pregnancy Test
Diagnostic testWomen with child-bearing potential will undergo a urine pregnancy test during the screening visit.
Gastroscopy
Diagnostic testDuring 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.
Health-related quality of life (HR-QoL)
Diagnostic testA questionnaire assessing patient-reported satisfaction and function.
Visual Analogue Scale (VAS)
Diagnostic testA validated, subjective measure measuring acute and chronic pain.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Su2ura® GI System-study device groupExperimental treatment 9 interventions
Trial outcomes
Primary outcomes
1
Patients with incomplete closure.
Percentage of patients with incomplete closure.
Time frame
Up to 28 days2
Patients bleeding at closure site.
Percentage of patients bleeding at closure site within 28 days from procedure.
Time frame
Up to 28 days3
Patients with infection at closure site.
Percentage of patients with infection at closure site within 28 days from procedure.
Time frame
Up to 28 days4
Patients with leakage.
Percentage of patients with leakage within 72 hours from procedure.
Time frame
Up to 72 hoursSecondary outcomes
1
Overall rates of Serious Adverse Events
Overall rates of Serious Adverse Events will be recorded up to 180 days following the procedure.
Time frame
Up to 180 days2
Serious Adverse Device Effects
Serious Adverse Device Effects (SADE) will be evaluated endoscopically at 2-14 and 90 days.
Time frame
Up to 90 days3
Evidence of a Leak
Clinical, radiologic or endoscopic evidence of a Leak within 30 days
Time frame
Up to 30 days4
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.
Time frame
Up to 180 daysSponsors and contacts
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Source ClinicalTrials.gov