NCT06487026

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

July 5, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 27, 2024

Last Update Submit

June 27, 2024

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

  • 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.

    from Day 0 to 90

Secondary Outcomes (2)

  • Solicited events from Day 0 to 30

    from Day 0 to 30

  • Unsolicited adverse events from Day 0 to 90

    from Day 0 to 90

Study Arms (1)

MRgHIFU treatment arm

EXPERIMENTAL

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

Device: ArcBlate Focused Ultrasound Ablation System

Interventions

ArcBlate Focused Ultrasound Ablation SystemDEVICE

MR-guided High Intensity Focused Ultrasound (MRgHIFU)

MRgHIFU treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Completed 14-day evaluation in main study.
  • Will provide completed and signed written informed consents.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan District, 333, Taiwan

Location

Central Study Contacts

Feng-Xian Yan

CONTACT

+886-3-5712354angelay@episonica.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

August 1, 2024

Primary Completion

July 31, 2025

Study Completion

October 31, 2025

Last Updated

July 5, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(4)