Pain Resulting From Bone MetastasesBM019-RegistryNCT01834937
ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
An observational study of Pain Resulting From Bone Metastases, run by InSightec at 6 sites in United States.
Trial summary
The purpose of this enhanced surveillance study ("ESS") is to collect information regarding chronic adverse events that are possibly related to the ExAblate® System ("ExAblate") that are received by InSightec ("InSightec") following PMA approval. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Resulting From Bone Metastases
- What is being tested?
- ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2013to Apr 2017
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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
Study population: All consented patients from all participating US sites who receive the commercial ExAblate procedure during the first year after approval will be included. This study/registry will examine treatment background information such adverse events, primary cancer type, treatment frequency, etc., reported in patients undergoing the device procedure for the first two years of commercial experience.
This study collects safety data on patient treatments performed commercially under the FDA approved labeling.
- Eligibility is as per approved device indication.
- All registry-consented patients who undergo commercial ExAblate procedure for bone mets palliation after device approval.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Virginia
Charlottesville, Virginia, 22908
City of Hope
Duarte, California, 91010
Weill Cornell Medical Center
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94107
Stanford University
Stanford, California, 94305
About this study
Official title: A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
The purpose of this enhanced surveillance study ("ESS") is to collect information regarding chronic adverse events that are possibly related to the ExAblate® System ("ExAblate") that are received by InSightec ("InSightec") following PMA approval. This study will examine adverse events reported in patients undergoing the device procedure for the first two years of commercial experience. Other relevant data may be collected as well.
Read the detailed description
This proposed Registry will be performed in full compliance with all HIPAA rules and their implementations at potential participating sites. All patients planned to undergo the ExAblate procedure in a commercial setting after PMA approval will be offered a consent so they can be included in the ESS. Non-consenting patients will not be included in the ESS. However, information regarding the total number of subjects treated at each participating site with the device will also be collected.
InSightec will set up a (password protected) EDC database for the sites to enter the information of participating subjects treated with the ExAblate device from all U.S. sites using the ExAblate procedure for the bone metastases indication. This will occur for a total duration of 2 years following device approval. It should be noted that any adverse event that meets the Medical Device Report ("MDR") definition will be reported as an MDR as well.
There will be no control group. Reporting to FDA will occur at six-month intervals for the first two-years after PMA approval.
- Conditions
- Pain Resulting From Bone Metastases
- Being tested
- ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)
- Keywords
- ExAblate, MRgFUS, Bone Metastases, Pain Palliation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)Device
Focused Ultrasound Surgery - FUS delivered by ExAblate for the palliation of pain due to bone metastases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
This study is designed to collect safety data during the first two years of commercial use of ExAblate MRgFUS treatment for palliation of pain resulting from bone metastases.
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Enrollment Difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Resulting From Bone MetastasesStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834937
- Sponsor's protocol ID
- BM019-Registry
- Other IDs
- BM019-Registry
- Acronym
- BM019-Registry
- Status last verified
- Nov 2018
- First submitted
- 12 Apr 2013
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Approval Registry: ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
- ClinicalTrials.gov ID
- NCT01834937
- Acronym / sponsor ID
- BM019-Registry / BM019-Registry
- Conditions
- Pain Resulting From Bone Metastases
- Keywords
- ExAblate, MRgFUS, Bone Metastases, Pain Palliation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment Difficulties
- Enrolment
- 17 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Apr 2013 (estimated)
- 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.
The purpose of this enhanced surveillance study ("ESS") is to collect information regarding chronic adverse events that are possibly related to the ExAblate® System ("ExAblate") that are received by InSightec ("InSightec") following PMA approval. This study will examine adverse events reported in patients undergoing the device procedure for the first two years of commercial experience. Other relevant data may be collected as well.
Detailed description
This proposed Registry will be performed in full compliance with all HIPAA rules and their implementations at potential participating sites. All patients planned to undergo the ExAblate procedure in a commercial setting after PMA approval will be offered a consent so they can be included in the ESS. Non-consenting patients will not be included in the ESS. However, information regarding the total number of subjects treated at each participating site with the device will also be collected.
InSightec will set up a (password protected) EDC database for the sites to enter the information of participating subjects treated with the ExAblate device from all U.S. sites using the ExAblate procedure for the bone metastases indication. This will occur for a total duration of 2 years following device approval. It should be noted that any adverse event that meets the Medical Device Report ("MDR") definition will be reported as an MDR as well.
There will be no control group. Reporting to FDA will occur at six-month intervals for the first two-years after PMA approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consented patients from all participating US sites who receive the commercial ExAblate procedure during the first year after approval will be included. This study/registry will examine treatment background information such adverse events, primary cancer type, treatment frequency, etc., reported in patients undergoing the device procedure for the first two years of commercial experience.
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 |
|---|---|---|
| ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)Focused Ultrasound Surgery - FUS delivered by ExAblate for the palliation of pain due to bone metastases. | Device | – |
Primary outcome
Adverse Events
Time frame: Two Years
This study is designed to collect safety data during the first two years of commercial use of ExAblate MRgFUS treatment for palliation of pain resulting from bone metastases.
Results and safety
The study was stopped early (reason given: Enrollment Difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Resulting From Bone Metastases, run by InSightec at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study was stopped early (reason given: Enrollment Difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Two Years). 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 9 Nov 2018.