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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boston Scientific Radiofrequency Ablation Systems | Subjects with pain treated with a commercially approved Boston Scientific RF system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation | Device | Radiofrequency Ablation for treatment of chronic pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) | 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 | 12-months post-procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate | Percentage of subjects with a 30 percent or greater reduction from Baseline in targeted pain intensity | 12-months post-procedure |
Key Inclusion Criteria:
Key Exclusion Criteria:
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Patients with Chronic Pain
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons, M.S. | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elite Pain and Spine Institute | Mesa | Arizona | 85203 | United States | ||
| Tucson Orthopaedic Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40896553 | Derived | 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. | |
| 40342788 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Boston Scientific Radiofrequency Ablation Systems | Subjects with pain treated with a commercially approved Boston Scientific RF system Radiofrequency Ablation: Radiofrequency Ablation for treatment of chronic pain |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2024 |
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| Tucson |
| Arizona |
| 85712 |
| United States |
| The Spine Wellness Center in Westport | Westport | Connecticut | 06880 | United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Twin Cities Pain Clinic and Surgery Center | Edina | Minnesota | 55439 | United States |
| Carolinas Research Institute | Huntersville | North Carolina | 28078 | United States |
| UC Health Pain Medicine | Cincinnati | Ohio | 45219 | United States |
| Premier Pain Treatment Institute | Loveland | Ohio | 45140 | United States |
| Toledo Clinic | Toledo | Ohio | 43623 | United States |
| Pain Diagnostics and Interventional Care | Sewickley | Pennsylvania | 15143 | United States |
| ZNA Hoge Beuken | Antwerp | Belgium |
| St. Jan | Bruges | Belgium |
| Mater Olbia Hospital | Olbia | Italy |
| St. Anna Hospital | Geldrop | Netherlands |
| Derived |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline participants represent participants consented with Initial Radiofrequency Ablation (RFA) procedure. Participants included in the Participant Flow (298) all consented subjects only. Difference in number is due to subjects being consented but not having an initial RFA procedure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Boston Scientific Radiofrequency Ablation Systems | Subjects with pain treated with a commercially approved Boston Scientific RF system Radiofrequency Ablation: Radiofrequency Ablation for treatment of chronic pain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Data is based 294 subjects who provided consent and an initial RFA procedures. Participant evaluates all of the race/ethnicity categories and "check all that apply" per participant. 28 of the 294 subjects did not report any race/ethnicity information. 266 of the 294 subjects provided responses to the race/ethnicity information. This resulted in 269 responses from those 266 subjects. | Number | participants in category |
| ||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Numeric Rating Scale | The Numeric Rating Scale is a tool for patient self-reporting of pain. The scale consists of 11 points, ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable" | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Global Impression of Change (PGIC) | 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 | Posted | Count of Participants | Participants | 12-months post-procedure |
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| |||||||||||||||||||||||||||||||
| Other Pre-specified | Responder Rate | Percentage of subjects with a 30 percent or greater reduction from Baseline in targeted pain intensity | Posted | Count of Participants | Participants | 12-months post-procedure |
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From the time a subject signs the study Informed Consent through study completion or study withdrawal (up to 24 months).
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device and procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device and/or procedure were not collected or assessed in this study.
All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Boston Scientific Radiofrequency Ablation Systems | Subjects with pain treated with a commercially approved Boston Scientific RF system Radiofrequency Ablation: Radiofrequency Ablation for treatment of chronic pain | 0 | 298 | 44 | 298 | 0 | 298 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Abdominal infection | Infections and infestations | Systematic Assessment |
| ||
| Abscess limb | Infections and infestations | Systematic Assessment |
| ||
| Arthritis bacterial | Infections and infestations | Systematic Assessment |
| ||
| Bacterial infection | Infections and infestations | Systematic Assessment |
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| Device related infection | Infections and infestations | Systematic Assessment |
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| Diverticulitis | Infections and infestations | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | Systematic Assessment |
| ||
| Haematoma infection | Infections and infestations | Systematic Assessment |
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| Localised infection | Infections and infestations | Systematic Assessment |
| ||
| Mastitis | Infections and infestations | Systematic Assessment |
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| Meningitis | Infections and infestations | Systematic Assessment |
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| Post procedural pneumonia | Infections and infestations | Systematic Assessment |
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| Post Wound Infection | Infections and infestations | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
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| Coronary Artery disease | Cardiac disorders | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hip Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post Procedural complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal polyp haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Peptic ulcer perforation | Gastrointestinal disorders | Systematic Assessment |
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| Nerve compression | Nervous system disorders | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Deafness unilateral | Ear and labyrinth disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pumonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ostic ischaemic neuropathy | Eye disorders | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
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| Borderline personality disorder | Psychiatric disorders | Systematic Assessment |
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| Thrombosis | Vascular disorders | Systematic Assessment |
|
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A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | Boston Scientific Corporation | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Feb 2, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Black, of African heritage |
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| White |
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| Hispanic or Latino |
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| Native Hawaiian or other Pacific Islander |
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| Other |
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| Not disclosed |
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| Data Missing |
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| United States |
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| No change |
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| Minimally worse |
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| Much worse |
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| Very much worse |
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| Title | Denominators | Categories |
|---|
|