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

Boston Scientific

Status: Enrolling

Conditions: Essential Tremor; Dystonia; Movement Disorders; Parkinson Disease

Treatments: Device: Radiofrequency Ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT06553625

92802182 (Other Identifier)

A4106 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Boston Scientific Radiofrequency Ablation Systems

Description:

Subjects treated with Boston Scientific commercially approved radiofrequency (RF) ablation systems in the central nervous system (CNS).

Treatment:

Device: Radiofrequency Ablation