Bone MetastasesNCT06487026
Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases: An Extension Study
A study testing ArcBlate Focused Ultrasound Ablation System in people with Bone Metastases, run by EpiSonica at 4 sites in Taiwan.
Trial summary
An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- ArcBlate Focused Ultrasound Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesTaiwan
- Study dates
- 1 Aug 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women.
- Subjects who do not meet any of the inclusion criteria in CTP-BM-22-01 Study (i.e. main study) after re-evaluation.
- Determined by the investigator to be not suitable for the conduct of the study for any other reasons.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Far Eastern Memorial Hospital
New Taipei City, 220
Taichung Veterans General Hospital
Taichung, 407
National Taiwan University Hospital
Taipei, 100
Chang Gung Memorial Hospital - Linkou
Taoyuan, 333
About this study
Official title: 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
Read the detailed description
Pain palliation of bone metastasis through localized denervation by thermal ablation.
- Conditions
- Bone Metastases
- Being tested
- ArcBlate Focused Ultrasound Ablation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArcBlate Focused Ultrasound Ablation SystemDevice
MR-guided High Intensity Focused Ultrasound (MRgHIFU)
| Study group | Role | What they receive |
|---|---|---|
| MRgHIFU treatment arm | Experimental | Subjects will receive MRgHIFU treatment by using ArcBlate Focused Ultrasound Ablation System. Receives: Device: ArcBlate Focused Ultrasound Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from Day 0 to 90
Secondary outcomes (2)
Solicited events from Day 0 to 30
Major adverse events (Day 0 to 7)、Solicited adverse events (Day 0 to 30)
Measured: 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.
Measured: from Day 0 to 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EpiSonica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487026
- Sponsor's protocol ID
- CTP-BM-23-01
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases
- ClinicalTrials.gov ID
- NCT06487026
- Acronym / sponsor ID
- CTP-BM-23-01
- Conditions
- Bone Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- EpiSonicaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases
Detailed description
Pain palliation of bone metastasis through localized denervation by thermal ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRgHIFU treatment arm | Experimental | Device: ArcBlate Focused Ultrasound Ablation SystemSubjects will receive MRgHIFU treatment by using ArcBlate Focused Ultrasound Ablation System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant women.
- Subjects who do not meet any of the inclusion criteria in CTP-BM-22-01 Study (i.e. main study) after re-evaluation.
- Determined by the investigator to be not suitable for the conduct of the study for any other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArcBlate Focused Ultrasound Ablation SystemMR-guided High Intensity Focused Ultrasound (MRgHIFU) | Device | MRgHIFU treatment arm |
Primary outcome
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.
2 secondary outcomes
Solicited events from Day 0 to 30
Time frame: from Day 0 to 30
Unsolicited adverse events from Day 0 to 90
Time frame: from Day 0 to 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArcBlate Focused Ultrasound Ablation System in people with Bone Metastases, run by EpiSonica at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng-Xian Yan (+886-3-5712354, angelay@episonica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unanticipated adverse device effects (UADEs) from Day 0 to 90. (time frame: from Day 0 to 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.