Radiofrequency (RF) Ablation Prospective Outcomes Study

Pain, Chronic Clinical Trial

— RAPID  

Official title:

Radiofrequency (RF) Ablation Prospective Outcomes Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04673032
• Other study ID #: A4087
• Secondary ID: A4106
• Status: Recruiting
• Start date: December 22, 2020
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Gerard Herro
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 and in use for central nervous system (CNS) applications for other disorders.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

Key Inclusion Criteria:

• Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain or for CNS applications 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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Device:
• Radiofrequency Ablation
Radiofrequency Ablation for treatment of chronic pain or other disorders

Locations

Country	Name	City	State
Belgium	St. Jan	Brugge
Germany	Universitaetsklinikum Dusseldorf	Düsseldorf
Italy	Mater Olbia Hospital	Olbia
Netherlands	St. Anna Hospital	Geldrop
United Kingdom	St. Georges Hospital	London
United States	Shepherd Center	Atlanta	Georgia
United States	UC Health Pain Medicine	Cincinnati	Ohio
United States	Twin Cities Pain Clinic and Surgery Center	Edina	Minnesota
United States	The University of Florida Shands	Gainesville	Florida
United States	Carolinas Research Institute	Huntersville	North Carolina
United States	Premier Pain Treatment Institute	Loveland	Ohio
United States	Elite Pain and Spine Institute	Mesa	Arizona
United States	Quincy Medical Group	Quincy	Illinois
United States	Pain Diagnostics and Interventional Care	Sewickley	Pennsylvania
United States	Toledo Clinic	Toledo	Ohio
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	The Spine Wellness Center in Westport	Westport	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Up to 24 months post-procedure
Primary	Responder rate	Proportion of subjects with a 30 percent or greater reduction from Baseline in targeted pain intensity	1 month post-procedure