Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

Description

The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal. The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.

Conditions

Rib Fractures

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Study Overview

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Study Details

Study overview

The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal. The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.

Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)

Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

Condition
Rib Fractures
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford Hospital and Clinics, Palo Alto, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients 18 to 64 years with any acute rib fracture between rib 3 and rib 9
  • * Pain score equal to or greater than 5 with deep inspiration
  • * Presenting and admitted to Stanford Adult Emergency Department, having a trauma consult, and being admitted to the trauma floors of Stanford Healthcare (SHC) for their inpatient stay
  • * Radiographic evidence of metastasis to ribs
  • * Glasgow Coma Scale (GCS) score \<13
  • * Patients undergoing SSRF (Surgical stabilization of rib fractures)
  • * Rib fractures located \< 3cm from spinous process
  • * Coagulopathy (INR \>1.5, Plt \< 100)
  • * Other factors precluding cryoneurolysis at the attending's discretion
  • * If only ribs broken are 1,2 or 10,11,12
  • * Inability to be positioned for the procedure
  • * If the patient has the following conditions that the manufacturer of the Iovera device advises AGAINST using the device if present: Cryoglobulinemia, Paroxysmal cold hemoglobinuria, Cold urticaria, Raynaud's disease, open and/or infected wounds at or near the treatment site.

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Joseph D Forrester, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Ara Ko, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2026-01-01