Radiofrequency (RF) Ablation Prospective Outcomes Study

Completed

• Conditions: Pain, Chronic
• Interventions: Device: Radiofrequency Ablation

• 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

Study Timeline

• Study First Submitted: 2020-12-12
• Study First Submitted QC: 2020-12-12
• Study First Posted: 2020-12-17
• Study Start: 2020-12-22
• Primary Completion: 2025-02-07
• Study Completion: 2025-02-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13

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

Arm && Interventions

Group	Intervention	Description
Boston Scientific Radiofrequency Ablation Systems	Radiofrequency Ablation	Subjects with pain treated with a commercially approved Boston Scientific RF system

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

Trial Locations

Locations (15)

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

ZNA Hoge Beuken; 🇧🇪 Antwerp, Belgium

St. Jan; 🇧🇪 Brugge, Belgium

Mater Olbia Hospital; 🇮🇹 Olbia, Italy

St. Anna Hospital; 🇳🇱 Geldrop, Netherlands

Twin Cities Pain Clinic and Surgery Center; 🇺🇸 Edina, Minnesota, United States

Tucson Orthopaedic Institute; 🇺🇸 Tucson, Arizona, United States

Elite Pain and Spine Institute; 🇺🇸 Mesa, Arizona, United States

The Spine Wellness Center in Westport; 🇺🇸 Westport, Connecticut, United States

Shepherd Center; 🇺🇸 Atlanta, Georgia, United States

Pain Diagnostics and Interventional Care; 🇺🇸 Sewickley, Pennsylvania, United States

Quincy Medical Group; 🇺🇸 Quincy, Illinois, United States