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

NCT ID: NCT06487026

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-10-31

Brief Summary

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

Detailed Description

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

Conditions

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Bone Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRgHIFU treatment arm

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

Group Type EXPERIMENTAL

ArcBlate Focused Ultrasound Ablation System

Intervention Type DEVICE

MR-guided High Intensity Focused Ultrasound (MRgHIFU)

Interventions

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ArcBlate Focused Ultrasound Ablation System

MR-guided High Intensity Focused Ultrasound (MRgHIFU)

Intervention Type DEVICE

Eligibility Criteria

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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.

3. Determined by the investigator to be not suitable for the conduct of the study for any other reasons.

Exclusion Criteria

1. Pregnant women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EpiSonica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital - Linkou

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Feng-Xian Yan

Role: CONTACT

+886-3-5712354

Other Identifiers

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CTP-BM-23-01

Identifier Type: -

Identifier Source: org_study_id

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