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Not Yet Recruiting NCT07874724

Cryoneurolysis for Abdominal Wall Relaxation Prior to Ventral Hernia Repair

Conditions: Ventral Hernia, Incisional Hernia, Hernia, Hernia Abdominal Wall, Hernia Incisional, Hernia Incisional Ventral, Hernia of Abdominal Wall, Hernia Surgery

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: University of South Florida

Location: University of South Florida Tampa Florida

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

Eligibility Criteria

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: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07874724). StuddyBuddy aggregates publicly available trial information.