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Radiofrequency (RF) Ablation Prospective Outcomes Study

Completed
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
Inclusion Criteria
  • 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

Exclusion Criteria
  • 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
NameTimeMethod
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
NameTimeMethod

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

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