Cryoablation for Rib Fractures

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Loma Linda University

Trial Summary

What is the purpose of this trial?

The goal of this double blinded randomized control trial is to learn if percutaneous cryoablation of traumatic rib fractures improves outcomes. The main questions it aims to answer are: Does percutaneous cryoablation improve short and long term pain scores? Does percutaneous cryoablation improve short and long term respiratory mechanics? Does percutaneous cryoablation improve long term quality of life? Does percutaneous cryoablation decrease delirium? Researchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery. Participants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.

Research Team

Eligibility Criteria

This trial is for individuals with traumatic rib fractures. It's designed to help those experiencing chest pain, respiratory issues, or other complications from broken ribs. Participants should be able to undergo the procedure and follow-up tests.

Inclusion Criteria

I am older than 18 years.

Presence of > 2 rib fractures

Incentive Spirometry < 60% of predicted

Exclusion Criteria

Life Expectancy < 6 months

I have extensive air pockets under my skin.

I do not have bleeding disorders or shock currently.

Treatment Details

Interventions

• Percutaneous Cryoablation of Intercostal Nerves (Procedure)

Trial Overview The study compares percutaneous cryoablation—a technique that freezes nerves—to standard pain treatments in managing rib fracture outcomes. It looks at how each method affects pain relief, breathing function, quality of life, and delirium rates over time.

Participant Groups

Group I: Standard multi-modal pain regimen with percutaneous cryoablation Experimental Treatment 2 Interventions

Group II: Standard multi-modal pain regimen alone Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Adrian Cotton

Loma Linda University

Chief Medical Officer since 2020

MD

Richard H. Hart

Loma Linda University

Chief Executive Officer since 2015

MD, DrPH