Search > Incisional Hernia
My employer runs this trial

Cryoneurolysis for Ventral Hernia

MP
AS
Overseen ByAdham Saad, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if cryoneurolysis, a targeted cold therapy applied to nerve branches, can relax the muscles of the abdomen to facilitate surgical repair of abdominal wall hernias. The main questions it aims to answer are:

* Does cryoneurolysis result in changes to the length of the abdominal oblique muscles and hernia size?

* Are there any side effects with the procedure?

* What are the rates of complete hernia closure and component separation at the time of hernia repair?

Participants will

* Undergo cryoneurolysis procedure between two to six weeks prior to scheduled hernia repair

* Complete a telephone visit 24-48 hours after the procedure to review any side effects

* Undergo repeat computed tomography (CT) scan one to two weeks after the procedure to detect changes to the abdominal muscles and hernia size

* Undergo routine postoperative clinic visits including 30 days after hernia repair surgery

Who Is on the Research Team?

MP

Monica Polcz, MD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for adults scheduled to have surgery to repair an abdominal (ventral or incisional) hernia. Participants must be able to undergo both the cryoneurolysis procedure and follow-up visits before their planned hernia surgery.

Inclusion Criteria

CT scan available within the past 6 months demonstrating ventral hernia transverse defect size greater than 8 centimeters or loss of domain defined as Tanaka index of 0.25 or greater
I am planning to have surgery to repair a ventral hernia.

Exclusion Criteria

I have a neuromuscular disorder.
Thrombocytopenia, elevated INR, and/or elevated PTT outside normal lab value range
Women of childbearing potential not protected by effective contraception or unwilling/unable to be tested for pregnancy
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Cryoneurolysis

Trial Overview

The study tests whether cryoneurolysis—a cold therapy applied to nerves—can relax abdominal muscles and help with hernia repair. The treatment is done a few weeks before surgery, followed by scans and check-ins to monitor effects.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CryoneurolysisExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.