COMPLETED

Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-02-21
Study Completion:2026-02-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05330611

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.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients 18 to 64 years with any acute rib fracture between rib 3 and rib 9
  2. * Pain score equal to or greater than 5 with deep inspiration
  3. * 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
  1. * Radiographic evidence of metastasis to ribs
  2. * Glasgow Coma Scale (GCS) score \<13
  3. * Patients undergoing SSRF (Surgical stabilization of rib fractures)
  4. * Rib fractures located \< 3cm from spinous process
  5. * Coagulopathy (INR \>1.5, Plt \< 100)
  6. * Other factors precluding cryoneurolysis at the attending's discretion
  7. * If only ribs broken are 1,2 or 10,11,12
  8. * Inability to be positioned for the procedure
  9. * 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.

Contacts and Locations

Principal Investigator

Joseph D Forrester, MD
PRINCIPAL_INVESTIGATOR
Stanford University
Ariel Knight, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Stanford University

  • Joseph D Forrester, MD, PRINCIPAL_INVESTIGATOR, Stanford University
  • Ariel Knight, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-21
Study Completion Date2026-02-02

Study Record Updates

Study Start Date2023-02-21
Study Completion Date2026-02-02

Terms related to this study

Keywords Provided by Researchers

  • Percutaneous Cryoneurolysis

Additional Relevant MeSH Terms

  • Rib Fractures