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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-29

Study Completion Date

2035-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease Dystonia Essential Tremor Movement Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Boston Scientific Radiofrequency Ablation Systems

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

Radiofrequency Ablation

Intervention Type DEVICE

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

Interventions

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Radiofrequency Ablation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No