Uterine Fibroids (Leiomyomas)NCT01946178
Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids
A study testing Mirabilis High-Intensity Focused Ultrasound Treatment System in people with Uterine Fibroids (Leiomyomas), run by Mirabilis Medica, Inc. at 2 sites in Mexico.
Trial summary
The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Uterine Fibroids (Leiomyomas)
- What is being tested?
- Mirabilis High-Intensity Focused Ultrasound Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesMexico
- Study dates
- Jan 2011to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Age 18-55 years
- Patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology
- Patients able and willing to provide informed consent
Who cannot join
- Visible scar within the HIFU beam path that cannot be avoided
- Known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall
- Currently pregnant or desire to become pregnant in the future
- Pelvic malignancy
- Pelvic congenital malformation
- Acute pelvic infection
- Otherwise determined by a physician to be inappropriate for the study
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Hospital Torre Medica
Mexico City, Mexico City, 06030
Hospital Universitario, Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo León, 64460
About this study
Official title: Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia
The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.
- Conditions
- Uterine Fibroids (Leiomyomas)
- Being tested
- Mirabilis High-Intensity Focused Ultrasound Treatment System
- Keywords
- Uterine Fibroids, Leiomyomas, High-Intensity Focused Ultrasound Ablation, Ultrasonography
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabilis High-Intensity Focused Ultrasound Treatment SystemDevice
The intervention consists of a treatment session with the device, during which focused ultrasound energy is applied across the intact abdominal wall to ablate appropriately selected uterine fibroids under ultrasound imaging guidance.
| Study group | Role | What they receive |
|---|---|---|
| Focused ultrasound treatment | Experimental | Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System. Receives: Device: Mirabilis High-Intensity Focused Ultrasound Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of All Adverse Events Encountered
Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.
Measured: Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).
Secondary outcomes (1)
HIFU-related Non-Perfused Volume (NPV)
Efficacy of the treatment was quantified by measuring the HIFU-related Non-Perfused Volume (NPV) of tissue in each patient using either post-treatment contrast-enhanced magnetic resonance imaging (MRI) or pathology assessment following hysterectomy. The NPV is used to measure the amount of tissue that was treated during the procedure.
Measured: The NPV was measured between 0 and 7 days post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJan 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids (Leiomyomas)Studies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirabilis Medica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lau, M.D., Study director, Mirabilis Medica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946178
- Sponsor's protocol ID
- No. 1006
- Status last verified
- Apr 2017
- First submitted
- 16 Sep 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Parsons JE, Lau MPH, Martin PJ, Islas Lagos JJ, Aguilar Aguirre JM, Garza Leal JG. Pilot Study of the Mirabilis System Prototype for Rapid Noninvasive Uterine Myoma Treatment Using an Ultrasound-Guided Volumetric Shell Ablation Technique. J Minim Invasive Gynecol. 2017 May-Jun;24(4):579-591. doi: 10.1016/j.jmig.2017.01.010. Epub 2017 Jan 18.
PubMed 28109895Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Darlington GP, and Lau MPH. In-Office Rapid Volumetric Ablation of Uterine Fibroids under Ultrasound Imaging Guidance: Preclinical and Early Clinical Experience with the Mirabilis Transabdominal HIFU Treatment System. Proceedings of the 14th International Symposium on Therapeutic Ultrasound. AIP Conference Proceedings 1821: 020001 (2017).
Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Martin PM, and Lau MPH. Refinement of the Shell Ablation Technique for Rapid In-Office Treatment of Uterine Fibroids under Ultrasound Imaging Guidance using the Mirabilis Transabdominal HIFU System. 15th International Symposium on Therapeutic Ultrasound Program and Abstracts: 156 (2015).
Lau M, Aguilar Aguirre JM, Islas Lagos JJ, and Garza Leal JG. Office Based High-Speed Ultrasound Image Guided HIFU (High Intensity Focused Ultrasound) Ablation of Uterine Fibroids. Gynecol. Surg. 11 (Suppl. 1): 149-150 (2014).
Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Darlington GP, and Lau MPH. In-Office Rapid Volumetric Ablation of Uterine Fibroids under Ultrasound Imaging Guidance: Preclinical and Early Clinical Experience with the Mirabilis Transabdominal HIFU Treatment System. 14th International Symposium on Therapeutic Ultrasound Program and Abstracts: 43 (2014).
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia
- ClinicalTrials.gov ID
- NCT01946178
- Acronym / sponsor ID
- No. 1006
- Conditions
- Uterine Fibroids (Leiomyomas)
- Keywords
- Uterine Fibroids, Leiomyomas, High-Intensity Focused Ultrasound Ablation, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Mirabilis Medica, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Posted 25 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focused ultrasound treatment | Experimental | Device: Mirabilis High-Intensity Focused Ultrasound Treatment SystemPatients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Age 18-55 years
- Patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology
- Patients able and willing to provide informed consent
Key exclusion criteria (7 listed)
- Visible scar within the HIFU beam path that cannot be avoided
- Known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall
- Currently pregnant or desire to become pregnant in the future
- Pelvic malignancy
- Pelvic congenital malformation
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 |
|---|---|---|
| Mirabilis High-Intensity Focused Ultrasound Treatment SystemThe intervention consists of a treatment session with the device, during which focused ultrasound energy is applied across the intact abdominal wall to ablate appropriately selected uterine fibroids under ultrasound imaging guidance. | Device | Focused ultrasound treatment |
Primary outcome
Evaluation of All Adverse Events Encountered
Time frame: Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).
Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.
1 secondary outcome
HIFU-related Non-Perfused Volume (NPV)
Time frame: The NPV was measured between 0 and 7 days post-treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28109895Parsons JE, Lau MPH, Martin PJ, Islas Lagos JJ, Aguilar Aguirre JM, Garza Leal JG. Pilot Study of the Mirabilis System Prototype for Rapid Noninvasive Uterine Myoma Treatment Using an Ultrasound-Guided Volumetric Shell Ablation Technique. J Minim Invasive Gynecol. 2017 May-Jun;24(4):579-591. doi: 10.1016/j.jmig.2017.01.010. Epub 2017 Jan 18.
- Results publicationGarza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Darlington GP, and Lau MPH. In-Office Rapid Volumetric Ablation of Uterine Fibroids under Ultrasound Imaging Guidance: Preclinical and Early Clinical Experience with the Mirabilis Transabdominal HIFU Treatment System. Proceedings of the 14th International Symposium on Therapeutic Ultrasound. AIP Conference Proceedings 1821: 020001 (2017).
- Results publicationGarza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Martin PM, and Lau MPH. Refinement of the Shell Ablation Technique for Rapid In-Office Treatment of Uterine Fibroids under Ultrasound Imaging Guidance using the Mirabilis Transabdominal HIFU System. 15th International Symposium on Therapeutic Ultrasound Program and Abstracts: 156 (2015).
- Results publicationLau M, Aguilar Aguirre JM, Islas Lagos JJ, and Garza Leal JG. Office Based High-Speed Ultrasound Image Guided HIFU (High Intensity Focused Ultrasound) Ablation of Uterine Fibroids. Gynecol. Surg. 11 (Suppl. 1): 149-150 (2014).
- Results publicationGarza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Darlington GP, and Lau MPH. In-Office Rapid Volumetric Ablation of Uterine Fibroids under Ultrasound Imaging Guidance: Preclinical and Early Clinical Experience with the Mirabilis Transabdominal HIFU Treatment System. 14th International Symposium on Therapeutic Ultrasound Program and Abstracts: 43 (2014).
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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.
Michael Lau, M.D. study director
Mirabilis Medica, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirabilis High-Intensity Focused Ultrasound Treatment System in people with Uterine Fibroids (Leiomyomas), run by Mirabilis Medica, Inc. at 2 sites in Mexico.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of All Adverse Events Encountered (time frame: Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01946178, which also lists 5 linked publications.
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 30 May 2017.