Ventral HerniaNCT07874724
Cryoneurolysis for Abdominal Wall Relaxation Prior to Ventral Hernia Repair
A study testing Cryoneurolysis in people with Ventral Hernia and Incisional Hernia, run by University of South Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ventral Hernia, Incisional Hernia, Hernia
- What is being tested?
- Cryoneurolysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planning to undergo ventral hernia repair
- CT scan available within the past 6 months, demonstrating ventral hernia transverse defect size >8 centimeters (cm) or loss of domain (defined as Tanaka index [hernia sac volume:abdominal cavity volume] of 0.25 or greater)
Who cannot join
- Use of any anticoagulant or antiplatelet medications is an absolute exclusion criterion. No holding protocol exists for these medications, and patients currently taking any of the following agents are ineligible regardless of the ability to temporarily discontinue: aspirin (any dose), Plavix, clopidogrel, ticagrelor, prasugrel, dipyridamole, cilostazole, dabigatran, rivaroxaban, apixaban, warfarin, or enoxaparin.
- Neuromuscular disorders
- Thrombocytopenia, elevated international normalized ratio (INR), and/or elevated partial thromboplastin time (PTT) outside of normal lab value range
- Unable to provide informed consent to participate in the study Such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
- Pregnant or breast-feeding women or those who plan to become pregnant during the study
- Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
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- Patients with accepted contraindication to cryoneurolysis procedure including local site infection, cryoglobulinemia, or Raynaud's disease
- Presence of systemic infections
- Anatomical derangements that may prevent procedural success
- Individuals with needle phobias
- Patients with an implanted electronic device such as a pacemaker or defibrillator should not undergo the procedure unless approved by a medical specialist.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Adham Saad, MD contact
United States1 site
University of South Florida
Tampa, Florida, 33606
Monica Polcz, MD, 813-660-8781, monicapolcz@usf.edu
Monica Polcz, MD
About this study
Official title: Novel Application of Cryoneurolysis for Neuromuscular Relaxation Prior to Abdominal Wall Reconstruction
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?
Read more
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
- Conditions
- Ventral Hernia, Incisional Hernia, Hernia, Hernia Abdominal Wall, Hernia Incisional, Hernia Incisional Ventral
- Being tested
- Cryoneurolysis
- Keywords
- Cryoneurolysis, Ventral Hernia, Incisional Hernia, Ventral Hernia Repair, Incisional Hernia Repair
- Medical subject headings
- Hernia, Ventral, Incisional Hernia, Hernia, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisDevice
Targeted cold therapy to the motor nerve branches of the abdominal oblique muscles to temporarily relax the muscles before hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolysis | Experimental | Not described Receives: Device: Cryoneurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Computed Tomography (CT) measured length of oblique muscles and hernia defect size in centimeters
CT obtained 1-2 weeks post cryoneurolysis procedure will be compared to baseline CT to determine change in oblique muscle complex length and maximal transverse hernia defect size in centimeters
Measured: 2 weeks
Secondary outcomes (1)
Summary of treatment related adverse events
Telephone survey will assess for bruising, swelling, redness, altered sensation, pain, other patient reported side effects 24-48 hours post cryoneurolysis. Standard postoperative complications after hernia repair including surgical site infection, surgical site occurrence, major complication (Clavien Dindo >=3), and mortality, or any other patient reported adverse event will be collected through 30 day postoperative clinic visit
Measured: Telephone survey 48 hours post cryoneurolysis procedure through 30 day postoperative follow up after hernia repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Polcz, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874724
- Sponsor's protocol ID
- STUDY009570
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No