Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases: An Extension Study
ConditionBone Metastases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEpiSonica
About this trial
An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases
Eligibility criteria
Qualifiers
Male or female, who randomized into Sham control group and withdrew from CTP-BM-22-01 Study (i.e. main study) due to lack of efficacy.
Completed 14-day evaluation in main study.
Will provide completed and signed written informed consents.
Disqualifiers
Pregnant women.
Subjects who do not meet any of the inclusion criteria in CTP-BM-22-01 Study (i.e. main study) after re-evaluation.
Determined by the investigator to be not suitable for the conduct of the study for any other reasons.
Trial design
Treatments tested in this trial
- ArcBlate Focused Ultrasound Ablation System
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
4Far Eastern Memorial Hospital220, New Taipei City Taiwan
Taichung Veterans General Hospital407, Taichung Taiwan
National Taiwan University Hospital100, Taipei Taiwan
Chang Gung Memorial Hospital - Linkou333, Taoyuan Taiwan
Sponsors and collaborators
EpiSonica
Lead sponsor
Source ClinicalTrials.gov