NCT06533904 Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
| NCT ID | NCT06533904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Loma Linda University |
| Condition | Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-02 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-06-02 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * \> 18 years old * \> 2 rib fractures * Verbal Pain score \> 5 * Incentive Spirometry \< 60% of predicted Exclusion Criteria: * Isolated Fractures of Ribs 1-3 and/or 10-12 * Posterior Rib Fracture \< 4 cm from costovertebral joint * Sternal, Clavicle, Scapula Fracture * Thoracic Spinal Fracture of any type * Open Abdominothoracic Surgery * Unstable Spine * Extensive Subcutaneous Emphysema * BMI \> 35 * Plan for Rib Plating * Chronic Opioid Use * Prior to study enrollment: Intubated, Traumatic Brain Injury, Dementia, Cognitive Impairment, Encephalopathy * Coagulopathy, Shock at time of ablation * Inability to participate in activities of daily living prior to injury * Home O2 use prior to trauma * Inhalation Injury * Rib Fractures due to cardiopulmonary resuscitation * Life Expectancy \< 6 months * \> 48 hours from injury * Pregnant, Incarcerated
Frequently Asked Questions
Who can join the NCT06533904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06533904 currently recruiting?
Yes, NCT06533904 is actively recruiting participants. Visit ClinicalTrials.gov or contact Loma Linda University to inquire about joining.
Where is the NCT06533904 trial being conducted?
This trial is being conducted at Loma Linda, United States.
Who is sponsoring the NCT06533904 clinical trial?
NCT06533904 is sponsored by Loma Linda University. The trial plans to enroll 30 participants.