Status:
ACTIVE_NOT_RECRUITING
Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis
Lead Sponsor:
Stanford University
Conditions:
Rib Fractures
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for minimally invasive ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05330611
Start Date
February 21 2023
End Date
January 1 2026
Last Update
August 3 2025
Active Locations (1)
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1
Stanford Hospital and Clinics
Palo Alto, California, United States, 94305