Uterine FibroidsPROMISeNCT01377519
Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids
A study testing MR Guided Focused Ultrasound in people with Uterine Fibroids, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- MR Guided Focused Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2012
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Premenopausal
- Symptomatic fibroids
- Fibroids accessible for focused ultrasound treatment
Who cannot join
- Desires future fertility
- Current pregnancy
- Hematocrit <30%
- Emergency room visit in last 3 months for fibroid symptoms
- History of venous thromboembolism
- Fibroids that are: >10cm, non-enhancing with contrast
Show all 9Show fewer
- Adenomyosis
- Contraindications to undergoing MRI
- Unexplained menstrual irregularity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial
This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.
- Conditions
- Uterine Fibroids
- Being tested
- MR Guided Focused Ultrasound, Placebo MR Guided Focused Ultrasound
- Keywords
- Fibroids, Uterine, Focused Ultrasound, Magnetic Resonance focused ultrasound, HIFU, NOninvasive, Treatment
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR Guided Focused UltrasoundProcedure or surgery
This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.
Placebo MR Guided Focused UltrasoundProcedure or surgery
This is a placebo treatment that requires a participant to undergo identical procedures as those of the actual MR Guided Focused Ultrasound procedure, but higly focused ultrasound waves are not directed at the uterine fibroid.
| Study group | Role | What they receive |
|---|---|---|
| MR Guided Focused Ultrasound | Active comparator | Not described Receives: Procedure: MR Guided Focused Ultrasound |
| Placebo MR Guided Focused Ultrasound | Placebo comparator | Not described Receives: Procedure: Placebo MR Guided Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroid volume measured on MRI
Measured: Change from baseline prior to treatment until 3 months after treatment
Fibroid symptoms reported by participant
Measured: Change from baseline prior to treatment to 1 and 3 months after treatment
Red blood cell count (hematocrit)
Measured: Change from baseline prior to treatment and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Jacoby, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377519
- Sponsor's protocol ID
- 001
- Acronym
- PROMISe
- Status last verified
- Nov 2019
- First submitted
- 15 Jun 2011
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jacoby VL, Kohi MP, Poder L, Jacoby A, Lager J, Schembri M, Rieke V, Grady D, Vittinghoff E, Coakley FV. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids. Fertil Steril. 2016 Mar;105(3):773-780. doi: 10.1016/j.fertnstert.2015.11.014. Epub 2015 Dec 1.
PubMed 26658133
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01377519
- Acronym / sponsor ID
- PROMISe / 001
- Conditions
- Uterine Fibroids
- Keywords
- Fibroids, Uterine, Focused Ultrasound, Magnetic Resonance focused ultrasound, HIFU, NOninvasive, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Jun 2011 (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.
This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MR Guided Focused Ultrasound | Active comparator | Procedure: MR Guided Focused Ultrasound |
| Placebo MR Guided Focused Ultrasound | Placebo comparator | Procedure: Placebo MR Guided Focused Ultrasound |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18 years
- Premenopausal
- Symptomatic fibroids
- Fibroids accessible for focused ultrasound treatment
Key exclusion criteria (9 listed)
- Desires future fertility
- Current pregnancy
- Hematocrit <30%
- Emergency room visit in last 3 months for fibroid symptoms
- History of venous thromboembolism
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 |
|---|---|---|
| MR Guided Focused UltrasoundThis is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue. | Procedure or surgery | MR Guided Focused Ultrasound |
| Placebo MR Guided Focused UltrasoundThis is a placebo treatment that requires a participant to undergo identical procedures as those of the actual MR Guided Focused Ultrasound procedure, but higly focused ultrasound waves are not directed at the uterine fibroid. | Procedure or surgery | Placebo MR Guided Focused Ultrasound |
Primary outcome
Fibroid volume measured on MRI
Time frame: Change from baseline prior to treatment until 3 months after treatment
Fibroid symptoms reported by participant
Time frame: Change from baseline prior to treatment to 1 and 3 months after treatment
Red blood cell count (hematocrit)
Time frame: Change from baseline prior to treatment and 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 26658133Jacoby VL, Kohi MP, Poder L, Jacoby A, Lager J, Schembri M, Rieke V, Grady D, Vittinghoff E, Coakley FV. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids. Fertil Steril. 2016 Mar;105(3):773-780. doi: 10.1016/j.fertnstert.2015.11.014. Epub 2015 Dec 1.
- Fibroid trials at UCSFLink provided by the sponsor.
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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.
Vanessa Jacoby, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Guided Focused Ultrasound in people with Uterine Fibroids, run by University of California, San Francisco at 1 site 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?
The sponsor lists 4 inclusion and 9 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fibroid volume measured on MRI (time frame: Change from baseline prior to treatment until 3 months after treatment). The study lists 3 primary outcomes in all. 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 NCT01377519, which also lists 1 linked publication.
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 Nov 2019.