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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ArcBlate Focused Ultrasound Ablation System
DeviceMR-guided High Intensity Focused Ultrasound (MRgHIFU)
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: MRgHIFU treatment armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Unanticipated adverse device effects (UADEs) from Day 0 to 90.
UADEs is defined as any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Time frame
from Day 0 to 90Secondary outcomes
1
Solicited events from Day 0 to 30
Major adverse events (Day 0 to 7)、Solicited adverse events (Day 0 to 30)
Time frame
from Day 0 to 302
Unsolicited adverse events from Day 0 to 90
Unsolicited adverse events are defined as whose nature or intensity are not consistent with the solicited AE.
Time frame
from Day 0 to 90 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: