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

EpiSonica

Status: Not yet enrolling

Conditions: Bone Metastases

Treatments: Device: ArcBlate Focused Ultrasound Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06487026

CTP-BM-23-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

MRgHIFU treatment arm

Experimental group

Description:

Subjects will receive MRgHIFU treatment by using ArcBlate Focused Ultrasound Ablation System.

Treatment:

Device: ArcBlate Focused Ultrasound Ablation System