Radiofrequency (RF) Ablation Prospective Outcomes Study (RAPID)

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Device: Radiofrequency Ablation

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Stephanie Delvaux; Phone Number: 855-213-9890; Email: BSNClinicalTrials@bsci.com
• Study Contact Backup: Name: Gerard Herro; Phone Number: 855-213-9890; Email: BSNClinicalTrials@bsci.com

Study Locations

• Belgium
  • Brugge, Belgium
    • Active, not recruiting
    • St. Jan
• Germany
  • Düsseldorf, Germany
    • Recruiting
    • Universitaetsklinikum Dusseldorf
    • Contact: Boston Scientific Clinical Research; Phone Number: 855-213-9890; Email: BSNClinicalTrials@bsci.com
• Italy
  • Olbia, Italy
    • Active, not recruiting
    • Mater Olbia Hospital
• Netherlands
  • Geldrop, Netherlands
    • Active, not recruiting
    • St. Anna Hospital
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • St. Georges Hospital
    • Contact: Boston Scientific Clinical Research; Phone Number: 855-213-9890; Email: BSNClinicalTrials@bsci.com
• United States
  • Arizona
    • Mesa, Arizona, United States, 85203
      • Active, not recruiting
      • Elite Pain and Spine Institute
    • Tucson, Arizona, United States, 85712
      • Active, not recruiting
      • Tucson Orthopaedic Institute
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • Active, not recruiting
      • The Spine Wellness Center in Westport
  • Florida
    • Gainesville, Florida, United States, 32611
      • Active, not recruiting
      • The University of Florida Shands
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Active, not recruiting
      • Shepherd Center
  • Illinois
    • Quincy, Illinois, United States, 62301
      • Terminated
      • Quincy Medical Group
  • Minnesota
    • Edina, Minnesota, United States, 55439
      • Active, not recruiting
      • Twin Cities Pain Clinic and Surgery Center
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Active, not recruiting
      • Carolinas Research Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Active, not recruiting
      • UC Health Pain Medicine
    • Loveland, Ohio, United States, 45140
      • Active, not recruiting
      • Premier Pain Treatment Institute
    • Toledo, Ohio, United States, 43623
      • Terminated
      • Toledo Clinic
  • Pennsylvania
    • Sewickley, Pennsylvania, United States, 15143
      • Active, not recruiting
      • Pain Diagnostics and Interventional Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Pain and other disorders

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Boston Scientific Radiofrequency Ablation Systems; Subjects with pain or other disorders treated with a commercially approved Boston Scientific RF system	Device: Radiofrequency Ablation; Radiofrequency Ablation for treatment of chronic pain or other disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate	Proportion of subjects with a 30 percent or greater reduction from Baseline in targeted pain intensity	1 month post-procedure

Other Outcome Measures

Outcome Measure	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	Up to 24 months post-procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Natalie Bloom Lyons, M.S., Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Radiofrequency (RF)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: A4087; A4106 (Other Identifier: Boston Scientific Corporation U.S. Study)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes