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

  • STATUS
    Recruiting
  • End date
    Dec 11, 2023
  • participants needed
    60
  • sponsor
    Anchora Medical
Updated on 11 March 2022

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.

Description

This study will be performed in accordance with the design and specific provisions of this protocol, in accordance with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP), Title 21 of the Code of Federal Regulations (21 CFR), part 812 (Investigational Device Exemptions), and the applicable regulatory requirements.

The study is a prospective, multi-center, open study, to evaluate the efficacy and safety of the Su2ura® approximation device.

An abdominal hernia emerges through a preformed or acquired defect of the abdominal wall. The defect may be congenital (primary), acquired as a result of wear and tear (primary), or result from surgery or trauma, where failure of the abdominal wall to heal produces an incisional (non-primary) hernia. Examples of abdominal hernia include epigastric, umbilical and inguinal hernia. Patients may be asymptomatic or complain of a lump or pain. These patients are offered elective surgery. Patients may also present with complications necessitating emergency repair with or without additional resection of compromised viscera.

Ventral hernias are very common and do present a challenge because of the risk of recurrence. Besides the surgeon, these hernias are ideally managed by a dietitian, nurse, and a physical therapist. Patient education has been a very popular topic in literature and hospital settings. Giving patients literature and discussing outcomes with instructions on multiple aspects throughout their encounters has shown to be very effective.

The Su2ura Approximation Device is designed to deploy anchors threaded with stiches to facilitate tissue approximation by eliminating the need for the passing of a needle from one side of the tissue to the other as performed in traditional suturing. Utilizing the anchor feature allows a single action placement of a suture.

The principal investigator from each medical center participated in an appropriate training program. This training included the surgery procedure in an animal. The Principal investigators will train the sub investigators in this procedure. The sponsor will also provide training on the laparoscopic simulator to the principal investigators.

A total of 60 patients will be recruited to the study. Patients with a primary umbilical hernia under 2 cm will be recruited to the study and the hernia will be repaired with or without mesh according to the PI's decision.

Eligible patients with a primary or secondary ventral hernia, desiring an elective surgical repair, who amply the inclusion/Exclusion criteria will be offered to participate in the study.

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 12months post-surgery.

Details
Condition Ventral Hernia
Treatment blood tests, Physical Examination, Vital signs, Urine pregnancy test, Hernia repair surgery using the Su2ura® approximation device, Abdominal Ultrasound imaging, EuraHS-QoL, Visual Analouge Scale (VAS), Clinical evaluation for hernia recurrence and clinical bulging
Clinical Study IdentifierNCT04986917
SponsorAnchora Medical
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18 years
Patient desires an elective surgical repair
Patient is able to provide an informed consent
Diagnosis of a primary or secondary ventral hernia, with a fascial defect of width no more than 5 cm width in size on clinical examination or imaging scan
Body mass index (BMI) of 20-40 kg/m2
Candidate for laparoscopic repair based on the operating surgeon's assessment

Exclusion Criteria

Exclusion criteria 1. Diagnosis of concomitant abdominal wall defect(s) contiguous with
ventral hernia
Patient in need of concomitant non-hernia repair surgical procedure(s). 3. Patient in
need of emergent ventral 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. 6. Patient
has a history of an abdominal aortic aneurysm repair. 7. 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. 9. Patient was treated with
steroids in the past 6 months. 10. Patient with known collagen disorder. 11. Clean
contaminated/contaminated or dirty surgical field. 12. Patient is pregnant or intends to
become pregnant during the study period. 13. Patient has ascites on physical examination or
CT scan. 14. Patient has liver failure. 15. Patient undergoing dialysis treatment. 16
Patient has a wound-healing disorder. 17. 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
Patient in need of concomitant surgical procedures other than indicated in the protocol
as acceptable
Non-compliance with the study protocol. 22. Patient requests to exit the study. 23
Prior radiotherapy. 24. Active malignancy for at least 2 years. 25. Patients has Diastasis
recti more than 4cm×4cm size
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