Laparoscopic Ventral Hernia Repair with Routine Defect Closure Using Su2ura® Approximation Device

NACompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

January 19, 2022

Primary Completion Date

August 6, 2024

Study Completion Date

November 21, 2024

Conditions
Ventral Hernia
Interventions
DEVICE

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Vital Signs

Vital signs include blood pressure, pulse, temperature, body weight and height, body mass index (BMI).

DIAGNOSTIC_TEST

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."

DIAGNOSTIC_TEST

Urine Pregnancy Test

Urine pregnancy test will be performed during the screening visit (for WOCBP).

DIAGNOSTIC_TEST

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.

OTHER

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

OTHER

Visual Analouge Scale (VAS)

A validated, subjective measure measuring acute and chronic pain. questionnaire score range: 0-10; higher score indicates higher pain level.

DIAGNOSTIC_TEST

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."

Trial Locations (2)

Unknown

Hillel Yaffe Medical Center, Hadera

Barzilai Medical Center, Ashkelon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Anchora Medical

OTHER