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

Summary

Study includes 5 visits: Screening, Baseline/Surgery, and 14 days, 3 months, 12months Follow-Ups post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 12 months post-surgery.

Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered 30 min prior to skin incision. A surgical assistant will be selected by the PI from the surgical staff of the department.

The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura® approximation device and fixation of mesh with tacks over the closed defect in an IPOM fashion.

Based on surgeon consideration, primary umbilical hernia defects under 2 cm will be repaired with or without mesh.

Study follow-up visits will take place 14 days, 3 months and 12 months post-surgery.

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.

Sponsors & Collaborators

• Anchora Medical

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-19

Primary Completion

2024-08-06

Completion

2024-11-21

Countries

• Israel

Study Locations