Radiofrequency (RF) Ablation Prospective Outcomes Study
- Conditions
- Pain, Chronic
- Registration Number
- NCT04673032
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 298
- Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain per local Directions for Use (DFU)
- Signed a valid, IRB/EC/REB-approved informed consent form
Key
- Meets any contraindications per locally applicable Directions for Use (DFU)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient Global Impression of Change (PGIC) 12-months post-procedure 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Elite Pain and Spine Institute
🇺🇸Mesa, Arizona, United States
Tucson Orthopaedic Institute
🇺🇸Tucson, Arizona, United States
The Spine Wellness Center in Westport
🇺🇸Westport, Connecticut, United States
Shepherd Center
🇺🇸Atlanta, Georgia, United States
Quincy Medical Group
🇺🇸Quincy, Illinois, United States
Twin Cities Pain Clinic and Surgery Center
🇺🇸Edina, Minnesota, United States
Carolinas Research Institute
🇺🇸Huntersville, North Carolina, United States
UC Health Pain Medicine
🇺🇸Cincinnati, Ohio, United States
Premier Pain Treatment Institute
🇺🇸Loveland, Ohio, United States
Toledo Clinic
🇺🇸Toledo, Ohio, United States
Scroll for more (5 remaining)Elite Pain and Spine Institute🇺🇸Mesa, Arizona, United States