Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-22 @ 4:11 PM
Study NCT ID:
NCT06533904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-30
First Post:
2024-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012253', 'term': 'Rib Fractures'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will be randomized to standard multi-modal pain regimen with percutaneous cryoablation versus standard multi-modal pain regimen alone.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score: Numeric Pain Scale', 'timeFrame': 'Through study completion, up to 1 year', 'description': 'Short and Long Term Pain Scores. Range from 0 to 10 where 0 is no pain and 10 is most severe and worse outcome.'}, {'measure': 'Rate of abnormal respiratory mechanics: Incentive Spirometry', 'timeFrame': 'Through study completion, up to 1 year'}, {'measure': 'Rate of abnormal respiratory mechanics: Pulmonary Function Tests', 'timeFrame': 'Through study completion, up to 1 year', 'description': 'Short and Long Term Respiratory Mechanics. Pulmonary Function Tests will specifically measure Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)'}, {'measure': 'Rate of delirium: Confusion Assessment Method (CAM) Score', 'timeFrame': 'Through study completion, up to 1 year', 'description': 'The score ranges from 0 to 19. Where higher scores indicate more severe delirium and low scores indicate less severe or no delirium'}, {'measure': 'Quality of Life on Survey', 'timeFrame': 'Through study completion, up to 1 year', 'description': 'Long Term Quality of Life'}], 'secondaryOutcomes': [{'measure': 'Rate of Pneumonia', 'timeFrame': 'Through study completion, up to 1 year'}, {'measure': 'Rate of need for Intubation/Mechanical Ventilation', 'timeFrame': 'Through study completion, up to 1 year'}, {'measure': 'Rate of need for tracheostomy', 'timeFrame': 'Through study completion, up to 1 year'}, {'measure': 'Number of Ventilatory Days', 'timeFrame': 'Through study completion, up to 1 year'}, {'measure': 'ICU Length of Stay', 'timeFrame': 'Through study completion, up to 1 year'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Through study completion, up to 1 year'}, {'measure': 'Acute Respiratory Distress Syndrome', 'timeFrame': 'Through study completion, up to 1 year'}, {'measure': 'Rate of Mortality', 'timeFrame': 'Through study completion, up to 1 year'}, {'measure': 'Rate of Pleural Space Complications', 'timeFrame': 'Through study completion, up to 1 year', 'description': 'Hemothorax, Delayed hemothorax, Pneumothorax, Empyema, Hydrothorax, Rate of tube thoracostomy'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trauma', 'Respiratory Failure', 'Respiratory Distress', 'Respiratory Insufficiency', 'Rib Fractures', 'Chest Wall Trauma', 'Percutaneous Cryoablation', 'Multimodal Pain Therapy', 'Multimodal Pain Regimen'], 'conditions': ['Trauma', 'Rib Fractures', 'Chest Wall Disorder', 'Respiratory Insufficiency', 'Pain, Chest', 'Rib Trauma', 'Rib Fracture Multiple', 'Respiratory Failure', 'Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes 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?\n\nResearchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery.\n\nParticipants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years old\n* \\> 2 rib fractures\n* Verbal Pain score \\> 5\n* Incentive Spirometry \\< 60% of predicted\n\nExclusion Criteria:\n\n* Isolated Fractures of Ribs 1-3 and/or 10-12\n* Posterior Rib Fracture \\< 4 cm from costovertebral joint\n* Sternal, Clavicle, Scapula Fracture\n* Thoracic Spinal Fracture of any type\n* Open Abdominothoracic Surgery\n* Unstable Spine\n* Extensive Subcutaneous Emphysema\n* BMI \\> 35\n* Plan for Rib Plating\n* Chronic Opioid Use\n* Prior to study enrollment: Intubated, Traumatic Brain Injury, Dementia, Cognitive Impairment, Encephalopathy\n* Coagulopathy, Shock at time of ablation\n* Inability to participate in activities of daily living prior to injury\n* Home O2 use prior to trauma\n* Inhalation Injury\n* Rib Fractures due to cardiopulmonary resuscitation\n* Life Expectancy \\< 6 months\n* \\> 48 hours from injury\n* Pregnant, Incarcerated'}, 'identificationModule': {'nctId': 'NCT06533904', 'briefTitle': 'Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures', 'orgStudyIdInfo': {'id': '5240003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Standard multi-modal pain regimen alone', 'interventionNames': ['Other: Multi-modal pain regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Standard multi-modal pain regimen with percutaneous cryoablation', 'interventionNames': ['Procedure: Percutaneous Cryoablation of Intercostal Nerves', 'Other: Multi-modal pain regimen']}], 'interventions': [{'name': 'Percutaneous Cryoablation of Intercostal Nerves', 'type': 'PROCEDURE', 'description': 'Percutaneous Cryoablation of Intercostal Nerves', 'armGroupLabels': ['Standard multi-modal pain regimen with percutaneous cryoablation']}, {'name': 'Multi-modal pain regimen', 'type': 'OTHER', 'description': 'Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)', 'armGroupLabels': ['Standard multi-modal pain regimen alone', 'Standard multi-modal pain regimen with percutaneous cryoablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Martin G Rosenthal, MD', 'role': 'CONTACT', 'email': 'mrosenthal@llu.edu', 'phone': '909-558-4286'}, {'name': 'Matthew E Reeves, MD', 'role': 'CONTACT', 'email': 'mareeves@llu.edu', 'phone': '909-558-4289'}], 'facility': 'Loma Linda University Health', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}