Cryoneurolysis for Abdominal Wall Relaxation Prior to Ventral Hernia Repair

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07874724
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Oct 15, 2026
Start date
Nov 1, 2026
Status verified
Oct 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cryoneurolysis

Primary Outcome Measure

Change from baseline in Computed Tomography (CT) measured length of oblique muscles and hernia defect size in centimeters [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33606
Monica Polcz, MD
[email protected]
813-660-8781
Monica Polcz, MD (PRINCIPAL_INVESTIGATOR)
Adham Saad, MD (SUB_INVESTIGATOR)
Arun Kalava, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
University of South Florida· Tampa, FL

Related Studies