Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiofrequency Ablation.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Dystonia, Essential Tremor, Movement Disorders. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System
Overview
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.
Interventions
- Device Radiofrequency Ablation
Radiofrequency Ablation used in the central nervous system (CNS) in functional neurosurgery
Primary outcome measures
- Change in patient's quality of life (QoL) during the study as compared with baseline [Time frame: Up to 24-Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Uniklinik Köln — Cologne
- Universitaetsklinikum Dusseldorf — Düsseldorf
- Universitaetsklinikum Wuerzburg — Würzburg
United Kingdom · 1 center
- St. Georges Hospital — London
Identifiers
NCT: NCT06553625 · A4106 · 92802182