Recruiting

Cryoablation

Sponsor:

Loma Linda University

Code:

NCT06533904

Conditions

Trauma

Rib Fractures

Chest Wall Disorder

Respiratory Insufficiency

Pain, Chest

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Percutaneous Cryoablation of Intercostal Nerves

Multi-modal pain regimen

Study Details

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.

Conditions

Trauma

Rib Fractures

Chest Wall Disorder

Respiratory Insufficiency

Pain, Chest

Study ID

NCT06533904

Start date

Jun 2, 2024

Status verified date

Nov, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Standard multi-modal pain regimen alone

experimental: Standard multi-modal pain regimen with percutaneous cryoablation

Interventions

Percutaneous Cryoablation of Intercostal Nerves

Percutaneous Cryoablation of Intercostal Nerves

Multi-modal pain regimen

Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)

Primary outcome measure

  • Pain Score: Numeric Pain Scale [ Time Frame: Through study completion, up to 1 year ]
  • Rate of abnormal respiratory mechanics: Incentive Spirometry [ Time Frame: Through study completion, up to 1 year ]
  • Rate of abnormal respiratory mechanics: Pulmonary Function Tests [ Time Frame: Through study completion, up to 1 year ]
  • Rate of delirium: Confusion Assessment Method (CAM) Score [ Time Frame: Through study completion, up to 1 year ]
  • Quality of Life on Survey [ Time Frame: Through study completion, up to 1 year ]

Central Contacts and Locations

Locations

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Contacts

Martin G Rosenthal, MD

909-558-4286mrosenthal@llu.edu

Matthew E Reeves, MD

909-558-4289mareeves@llu.edu

More Information

Sponsor

Loma Linda University

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • Trauma
  • Respiratory Failure
  • Respiratory Distress
  • Respiratory Insufficiency
  • Rib Fractures
  • Chest Wall Trauma
  • Percutaneous Cryoablation
  • Multimodal Pain Therapy
  • Multimodal Pain Regimen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.