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

N/ANot Yet RecruitingNCT06487026

EpiSonica25 enrolled

Overview

An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases

Pain palliation of bone metastasis through localized denervation by thermal ablation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bone Metastases

Interventions

ArcBlate Focused Ultrasound Ablation SystemDEVICE

MR-guided High Intensity Focused Ultrasound (MRgHIFU)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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 District, Taiwan

Outcomes

Primary Outcomes

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 90

Secondary Outcomes

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 30

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

Central Contacts

Feng-Xian Yan

CONTACT

+886-3-5712354 angelay@episonica.com

Data from ClinicalTrials.gov

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