18
Participants
Start Date
January 19, 2022
Primary Completion Date
August 6, 2024
Study Completion Date
November 21, 2024
Hernia repair surgery using the Su2ura® approximation device
. The hernia defect will be measured and the Su2ura® approximation device will then be used to close the defect, placing stainless steel implantable anchors threaded on a Polyethylene braided surgical suture.
Physical Examination
All subjects 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
Vital signs include blood pressure, pulse, temperature, body weight and height, body mass index (BMI).
Blood Tests
"All subjects will undergo Hematology and Biochemistry blood tests. Blood Hematology test will include a complete CBC. Blood Biochemistry test will include the following measures: Sodium (Na), Potassium (K), Chloride (Cl), Creatinine, Glucose, Urea, Albumin, Calcium total, Alkaline Phosphatase (ALP), ALT, AST, Total Bilirubin, Direct Bilirubin, LDH, Total Protein, Uric Acid, CRP, and Lipid Profile (including Total Cholesterol, HDL, LDL, Triglycerides).~5 ml of blood (equals to 1 spoon) will be taken for each test."
Urine Pregnancy Test
Urine pregnancy test will be performed during the screening visit (for WOCBP).
Abdominal Ultrasound imaging
All subjects will undergo an abdominal ultrasound (US) imaging at 12 Months visit. The US will be performed to verify an absence of hernia recurrence.
EuraHS-QoL
patients will be asked to fill a questionnaire assessing patient-reported satisfaction and function. questionnaire score range: 0-180; higher score indicates higher pain and discomfort
Visual Analouge Scale (VAS)
A validated, subjective measure measuring acute and chronic pain. questionnaire score range: 0-10; higher score indicates higher pain level.
Clinical evaluation for hernia recurrence and clinical bulging
"The procedure includes:~1. Clinical examination to determine the presence of hernia recurrence and clinical bulging, in an inconclusive physical exam a radiological imaging will be performed such as US or CT.~2. SAE's and SADE's evaluation of the seroma.~3. Taking a photograph of the surgery area without disclosing the subject's identity."
Hillel Yaffe Medical Center, Hadera
Barzilai Medical Center, Ashkelon
Lead Sponsor
Anchora Medical
OTHER