Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS

June 10, 2026 updated by: Boston Scientific Corporation

Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System

The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to compile real-world outcomes of Boston Scientific Corporation commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Cologne, Germany
        • Recruiting
        • Uniklinik Köln
        • Contact:
      • Düsseldorf, Germany
        • Recruiting
        • Universitaetsklinikum Dusseldorf
        • Contact:
      • Würzburg, Germany
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • St. Georges Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients planned to receive treatment with a commercially approved Boston Scientific RF system to create lesions in the central nervous system (CNS) for use in functional neurosurgery.

Description

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Boston Scientific Radiofrequency Ablation Systems
Subjects treated with Boston Scientific commercially approved radiofrequency (RF) ablation systems in the central nervous system (CNS).
Device: Radiofrequency Ablation
Radiofrequency Ablation used in the central nervous system (CNS) in functional neurosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient's quality of life (QoL) during the study as compared with baseline
Time Frame: Up to 24-Months
Change in quality of life assessments during the study as compared with baseline
Up to 24-Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie M Bloom Lyons, M.A., Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4106 (Boston Scientific Corporation)
  • 92802182 (Other Identifier: Boston Scientific Corporation Protocol ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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