ClinicalTrials.gg
Not yet recruitingNCT07874724Updated Oct 15, 2026

Cryoneurolysis for Abdominal Wall Relaxation Prior to Ventral Hernia Repair

An interventional study of Cryoneurolysis in Ventral Hernia, Incisional Hernia and Hernia, sponsored by University of South Florida. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by University of South Florida · Not applicable, Interventional, and Basic science

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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
02

Conditions studied

  • Ventral Hernia
  • Incisional Hernia
  • Hernia
  • Hernia Abdominal Wall
  • Hernia Incisional
  • Hernia Incisional Ventral
  • Hernia of Abdominal Wall
  • Hernia Surgery

Keywords

  • Cryoneurolysis
  • Ventral Hernia
  • Incisional Hernia
  • Ventral Hernia Repair
  • Incisional Hernia Repair
03

In context

Hernia, Ventral

258 studies on the registry are indexed under Hernia, Ventral; 46 are open to participants now.

This study's planned enrollment of 10 is below the median of 95 across 163 interventional studies indexed under Hernia, Ventral.

Browse Hernia, Ventral studies →

Lead sponsor

University of South Florida is the lead sponsor of 338 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Cryoneurolysis

    Device: Cryoneurolysis

Interventions

  • DeviceCryoneurolysis

    Targeted cold therapy to the motor nerve branches of the abdominal oblique muscles to temporarily relax the muscles before hernia repair.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: Telephone survey 48 hours post cryoneurolysis procedure through 30 day postoperative follow up after hernia repair

Other outcomes

  1. Rate of primary fascial closure and need for surgical component separation at the time of hernia repair

    The investigators will prospectively capture intraoperative outcomes including rate of primary fascial closure, need for and type of component separation performed

    Time frame: At the time of surgery which will occur between 2-6 weeks post cryoneurolysis procedure

07

Study locations

1 site
  • University of South Florida
    Tampa, Florida 33606, United States
    • Monica Polcz, MD · Contact · monicapolcz@usf.edu · 813-660-8781
    • Monica Polcz, MD · Principal investigator
    • Adham Saad, MD · Sub investigator
    • Arun Kalava, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07874724
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Monica Polcz, MD MS
Contact
monicapolcz@usf.edu
813-660-8781
Adham Saad, MD
Contact
adhamsaad@usf.edu
Monica Polcz, MD
principal investigator · University of South Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion