Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBoston Scientific Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Radiofrequency Ablation
DeviceRadiofrequency Ablation used in the central nervous system (CNS) in functional neurosurgery
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Boston Scientific Radiofrequency Ablation Systems1 intervention
Trial outcomes
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
Time frame
Up to 24-MonthsSponsors and contacts
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Source ClinicalTrials.gov