Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases: An Extension Study

Not Applicable

Not yet recruiting

• Conditions: Bone Metastases

• Registration Number: NCT06487026
• Lead Sponsor: EpiSonica

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Study Start: 2024-08-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Unanticipated adverse device effects (UADEs) from Day 0 to 90.	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.

Secondary Outcome Measures

Name	Time	Method
Solicited events from Day 0 to 30	from Day 0 to 30	Major adverse events (Day 0 to 7)、Solicited adverse events (Day 0 to 30)
Unsolicited adverse events from Day 0 to 90	from Day 0 to 90	Unsolicited adverse events are defined as whose nature or intensity are not consistent with the solicited AE.

Trial Locations

Locations (4)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou; 🇨🇳 Taoyuan, Taiwan