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

June 27, 2024 updated by: EpiSonica

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital - Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRgHIFU treatment arm
Subjects will receive MRgHIFU treatment by using ArcBlate Focused Ultrasound Ablation System.
Device: ArcBlate Focused Ultrasound Ablation System
MR-guided High Intensity Focused Ultrasound (MRgHIFU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unanticipated adverse device effects (UADEs) from Day 0 to 90.
Time Frame: 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.
from Day 0 to 90

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EpiSonica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-BM-23-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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