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

Recruiting

• Conditions: Movement Disorders; Parkinson Disease; Dystonia; Essential Tremor
• Interventions: Device: Radiofrequency Ablation

• Registration Number: NCT06553625
• 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 used in the central nervous system (CNS) for use in functional neurosurgery.

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 Timeline

• Study Start: 2024-01-29
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Boston Scientific Radiofrequency Ablation Systems	Radiofrequency Ablation	Subjects treated with Boston Scientific commercially approved radiofrequency (RF) ablation systems in the central nervous system (CNS).

Primary Outcome Measures

Name	Time	Method
Change in patient's quality of life (QoL) during the study as compared with baseline	Up to 24-Months	Change in quality of life assessments during the study as compared with baseline

Trial Locations

Locations (3)

Uniklinik Köln; 🇩🇪 Cologne, Germany

Universitaetsklinikum Dusseldorf; 🇩🇪 Dusseldorf, Germany

St. Georges Hospital; 🇬🇧 London, United Kingdom