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Trial Title:
Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases: An Extension Study
NCT ID:
NCT06487026
Condition:
Bone Metastases
Conditions: Official terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
ArcBlate Focused Ultrasound Ablation System
Description:
MR-guided High Intensity Focused Ultrasound (MRgHIFU)
Arm group label:
MRgHIFU treatment arm
Summary:
An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful
Bone Metastases
Detailed description:
Pain palliation of bone metastasis through localized denervation by thermal ablation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Completed 14-day evaluation in main study.
3. Will provide completed and signed written informed consents.
Exclusion Criteria:
1. Pregnant women.
2. Subjects who do not meet any of the inclusion criteria in CTP-BM-22-01 Study (i.e.
main study) after re-evaluation.
3. Determined by the investigator to be not suitable for the conduct of the study for
any other reasons.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Far Eastern Memorial Hospital
Address:
City:
New Taipei City
Zip:
220
Country:
Taiwan
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
407
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Facility:
Name:
Chang Gung Memorial Hospital - Linkou
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Start date:
August 1, 2024
Completion date:
October 31, 2025
Lead sponsor:
Agency:
EpiSonica
Agency class:
Industry
Source:
EpiSonica
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06487026
