Status:
COMPLETED
Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation Device
Lead Sponsor:
Anchora Medical
Conditions:
Primary Umbilical Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Intended Use The Su2ura™ Approximation Device is indicated for tissue approximation in endoscopic and open surgery for the placement of interrupted or running stitches in soft tissue such as hernia re...
Detailed Description
DEVICE NAME AND INTENDED USE Device Name Su2ura™ Approximation Device Intended Use The Su2ura™ Approximation Device ("Su2ura approximation device") is indicated for tissue approximation in endoscopic...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Patient desires elective surgical repair
- Patient is able to give informed consent
- Diagnosis of a primary umbilical hernia with a fascial defect of width no more than 5 cm in size on clinical examination or CT scan
- Body mass index (BMI) 20-40 kg/m2
- Candidate for laparoscopic repair based on the operating surgeon's assessment
Exclusion
- Non-primary or incisional hernia in the umbilical hernia
- Diagnosis of concomitant abdominal wall defect(s) contiguous with primary umbilical hernia
- Patient previously underwent open or laparoscopic umbilical hernia repair surgery
- Patient previously underwent open or laparoscopic abdominal surgery which spans the umbilical area
- Patient in need of concomitant non-hernia repair surgical procedure(s)
- Patient in need of emergent primary umbilical hernia repair for complications such as incarceration, intestinal obstruction or strangulation
- The patient desires hernia repair using a technique other than that consistent with the study
- Patient has loss of domain as assessed on physical examination or CT scan
- Patient has a severe co-morbid condition likely to limit survival to less than 2 years
- Patient was treated with chemotherapy in the past 6 months
- Patient was treated with steroids in the past 6 months
- Pre-operative or intra-operative contamination of the surgical site
- Patient with known collagen disorder
- Patient is pregnant or intends to become pregnant during the study period
- Patient has ascites on physical examination or CT scan
- Patient has cirrhosis
- Patient undergoing dialysis treatment
- Patient has a wound-healing disorder
- Patient has an untreated coagulation disorder or is on anti-coagulant therapy not managed peri-operatively with the advice or supervision of a hematologist
- Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily
- Patient who is immunocompromised (including a diagnosis of HIV/AIDS, organ transplant, or receiving chemo- or radiation therapy
- Non-compliance with the study protocol
- Patient requests to exist the study
Key Trial Info
Start Date :
February 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04393532
Start Date
February 23 2020
End Date
April 18 2024
Last Update
January 22 2025
Active Locations (3)
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1
Ziv Medical Center
Safed, North, Israel, 13100
2
Barzilai Medical Center
Ashkelon, South, Israel, 7830604
3
Splošna bolnišnica Izola (General Hospital Izola)
Izola, Slovenia, 6310