Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT04673032
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2020-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiofrequency (RF) Ablation Prospective Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2020-12-12', 'studyFirstSubmitQcDate': '2020-12-12', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Responder rate', 'timeFrame': '3-months post-procedure', 'description': 'Proportion of subjects with a 30 percent or greater reduction from Baseline in targeted pain intensity'}], 'primaryOutcomes': [{'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': '12-months post-procedure', 'description': 'Using the Patient Global Impression of Change (PGIC) Scale, subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse compared with Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Radiofrequency (RF)'], 'conditions': ['Pain, Chronic']}, 'referencesModule': {'references': [{'pmid': '40896553', 'type': 'DERIVED', 'citation': 'Provenzano DA, Holt B, Danko M, Atallah J, Iqbal M, Shah B, Singh A, Sachdeva H, Donck EV, Liebrand B, Shaw E, Haas S, Sekhar R, Pan A, Halperin DS, Goldberg E. Assessment of real-world, prospective outcomes in patients treated with cervical radiofrequency ablation for chronic pain (RAPID). Interv Pain Med. 2025 Aug 23;4(3):100623. doi: 10.1016/j.inpm.2025.100623. eCollection 2025 Sep.'}, {'pmid': '40342788', 'type': 'DERIVED', 'citation': 'Provenzano DA, Holt B, Danko M, Atallah J, Iqbal M, Shah B, Singh A, Sachdeva H, Donck EV, Shaw E, Haas S, Sekhar R, Pan A, Halperin DS, Goldberg E. Assessment of real-world, prospective outcomes in patients treated with lumbar radiofrequency ablation for chronic pain (RAPID). Interv Pain Med. 2025 Apr 24;4(2):100576. doi: 10.1016/j.inpm.2025.100576. eCollection 2025 Jun.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems in the treatment of patients diagnosed with pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Chronic Pain', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain per local Directions for Use (DFU)\n* Signed a valid, IRB/EC/REB-approved informed consent form\n\nKey Exclusion Criteria:\n\n* Meets any contraindications per locally applicable Directions for Use (DFU)\n* Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments"}, 'identificationModule': {'nctId': 'NCT04673032', 'acronym': 'RAPID', 'briefTitle': 'Radiofrequency (RF) Ablation Prospective Outcomes Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Radiofrequency (RF) Ablation Prospective Outcomes Study', 'orgStudyIdInfo': {'id': 'A4087'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Boston Scientific Radiofrequency Ablation Systems', 'description': 'Subjects with pain treated with a commercially approved Boston Scientific RF system', 'interventionNames': ['Device: Radiofrequency Ablation']}], 'interventions': [{'name': 'Radiofrequency Ablation', 'type': 'DEVICE', 'description': 'Radiofrequency Ablation for treatment of chronic pain', 'armGroupLabels': ['Boston Scientific Radiofrequency Ablation Systems']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85203', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Elite Pain and Spine Institute', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Orthopaedic Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '06880', 'city': 'Westport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Spine Wellness Center in Westport', 'geoPoint': {'lat': 41.14149, 'lon': -73.3579}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '62301', 'city': 'Quincy', 'state': 'Illinois', 'country': 'United States', 'facility': 'Quincy Medical Group', 'geoPoint': {'lat': 39.9356, 'lon': -91.40987}}, {'zip': '55439', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Twin Cities Pain Clinic and Surgery Center', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Research Institute', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'UC Health Pain Medicine', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45140', 'city': 'Loveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Premier Pain Treatment Institute', 'geoPoint': {'lat': 39.26895, 'lon': -84.26383}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Clinic', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '15143', 'city': 'Sewickley', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pain Diagnostics and Interventional Care', 'geoPoint': {'lat': 40.53646, 'lon': -80.1845}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Hoge Beuken', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'St. Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Olbia', 'country': 'Italy', 'facility': 'Mater Olbia Hospital', 'geoPoint': {'lat': 40.92337, 'lon': 9.49802}}, {'city': 'Geldrop', 'country': 'Netherlands', 'facility': 'St. Anna Hospital', 'geoPoint': {'lat': 51.42167, 'lon': 5.55972}}], 'overallOfficials': [{'name': 'Natalie Bloom Lyons, M.S.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}