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

NCT06553625 | Recruiting FDA Device

• 2 other identifiers: A410692802182
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 4

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.

Conditions

Parkinson Disease; Dystonia; Essential Tremor; Movement Disorders

Outcome Measures

Primary Outcomes (1)

• Change in patient's quality of life (QoL) during the study as compared with baseline

  Change in quality of life assessments during the study as compared with baseline

  Up to 24-Months

Study Arms (1)

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

Interventions

Radiofrequency Ablation DEVICE

Radiofrequency Ablation used in the central nervous system (CNS) in functional neurosurgery

Boston Scientific Radiofrequency Ablation Systems

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

Uniklinik Köln

Cologne, Germany

RECRUITING

Universitaetsklinikum Dusseldorf

Düsseldorf, Germany

RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, Germany

RECRUITING

St. Georges Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Dystonia; Essential Tremor; Movement Disorders

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Natalie M Bloom Lyons, M.A.

  Boston Scientific Corporation

  STUDY DIRECTOR

Central Study Contacts

Stephanie Delvaux

CONTACT

855-213-9890; BSNClinicalTrials@bsci.com

Diane Keesey

CONTACT

855-213-9890; BSNClinicalTrials@bsci.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: January 29, 2024
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

DE (3); GB (1)