Status:
NOT_YET_RECRUITING
Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases: An Extension Study
Lead Sponsor:
EpiSonica
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06487026
Start Date
August 1 2024
End Date
October 31 2025
Last Update
July 5 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
2
Taichung Veterans General Hospital
Taichung, Taiwan, 407
3
National Taiwan University Hospital
Taipei, Taiwan, 100
4
Chang Gung Memorial Hospital - Linkou
Taoyuan District, Taiwan, 333