Uterine FibroidsNCT01588899
China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids
A study testing MR-HIFU uterine fibroid treatment in people with Uterine Fibroids, run by Philips Healthcare at 2 sites in China.
Trial summary
The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- MR-HIFU uterine fibroid treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesChina
- Study dates
- May 2012to May 2015
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women, age between 18 and 55 years
- Weight < 140 kg
- Pre- or peri-menopausal
- Uterine size < 24 weeks
- Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
- Fibroids selected for treatment meeting the following criteria:
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- Total planned ablation volume of all fibroids should not exceed 250 ml, and
- No more than 5 fibroids should be planned for ablation, and
- Dominant fibroid (diameter) is greater than or equal to 3 cm, and
- Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous
- Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be treated
- MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated
- Willing and able to attend all study visits
Who cannot join
- Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)
- Desire for future pregnancy
- Significant systemic disease, even if controlled
- Positive pregnancy test
- Hematocrit < 25%
- Extensive scarring along anterior lower abdominal wall (> 50% of area)
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- Surgical clips in the direct path of the HIFU beam
- MRI contraindicated
- MRI contrast agent contraindicated
- Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
- Calcifications around or throughout uterine tissues
- Communication barrier
- Suspected malignancy
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University First Hospital
Beijing, Beijing Municipality
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an
About this study
Official title: China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.
Read the detailed description
This study is to confirm the safety and effectiveness of Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women.
MR-HIFU uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and effectiveness of the Philips Sonalleve MR-HIFU device for uterine fibroids marketing approval in the Chinese market. MR-HIFU will be performed in 100 patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients at baseline and at 6 months post-treatment. All patients will be followed up for 12 months post-treatment for safety.
- Conditions
- Uterine Fibroids
- Being tested
- MR-HIFU uterine fibroid treatment
- Keywords
- Uterine Leiomyomas, Fibroids, HIFU, Ablation, High Intensity Focused Ultrasound
- Medical subject headings
- Leiomyoma, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-HIFU uterine fibroid treatmentDevice
Also called Philips Sonalleve MR-HIFU
A single treatment session for uterine fibroids with the MR-HIFU device.
| Study group | Role | What they receive |
|---|---|---|
| MR-HIFU Treatment | Experimental | Patients in this arm will receive MR-HIFU uterine fibroid treatment Receives: Device: MR-HIFU uterine fibroid treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fibroid volume
Proportion of patients with treated fibroid volume at 6 months after treatment reduced to 90% or less of treated fibroid volume at baseline (before MR-HIFU treatment)
Measured: At baseline and at 6 months after treatment
Adverse Events
Number of Adverse Events reported as resulting from MR-HIFU treatment
Measured: Within 6 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 posted1 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionMay 2015
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.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinping Liao, Principal investigator, Peking University First HospitalYueling Wang, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588899
- Sponsor's protocol ID
- 907764
- Status last verified
- Oct 2015
- First submitted
- 27 Apr 2012
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen R, Keserci B, Bi H, Han X, Wang X, Bai W, Wang Y, Yang X, Yang J, Wei J, Seppala M, Viitala A, Liao Q. The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China. J Ther Ultrasound. 2016 Nov 3;4:27. doi: 10.1186/s40349-016-0072-9. eCollection 2016.
PubMed 27822376
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
- ClinicalTrials.gov ID
- NCT01588899
- Acronym / sponsor ID
- 907764
- Conditions
- Uterine Fibroids
- Keywords
- Uterine Leiomyomas, Fibroids, HIFU, Ablation, High Intensity Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 May 2012 (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 study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.
Detailed description
This study is to confirm the safety and effectiveness of Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women.
MR-HIFU uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and effectiveness of the Philips Sonalleve MR-HIFU device for uterine fibroids marketing approval in the Chinese market. MR-HIFU will be performed in 100 patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients at baseline and at 6 months post-treatment. All patients will be followed up for 12 months post-treatment for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-HIFU Treatment | Experimental | Device: MR-HIFU uterine fibroid treatmentPatients in this arm will receive MR-HIFU uterine fibroid treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Women, age between 18 and 55 years
- Weight < 140 kg
- Pre- or peri-menopausal
- Uterine size < 24 weeks
- Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
Key exclusion criteria (13 listed)
- Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)
- Desire for future pregnancy
- Significant systemic disease, even if controlled
- Positive pregnancy test
- Hematocrit < 25%
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-HIFU uterine fibroid treatmentAlso: Philips Sonalleve MR-HIFUA single treatment session for uterine fibroids with the MR-HIFU device. | Device | MR-HIFU Treatment |
Primary outcome
Change in fibroid volume
Time frame: At baseline and at 6 months after treatment
Proportion of patients with treated fibroid volume at 6 months after treatment reduced to 90% or less of treated fibroid volume at baseline (before MR-HIFU treatment)
Adverse Events
Time frame: Within 6 months after treatment
Number of Adverse Events reported as resulting from MR-HIFU 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 22 Oct 2015.
- Derived from this study: PubMed 27822376Chen R, Keserci B, Bi H, Han X, Wang X, Bai W, Wang Y, Yang X, Yang J, Wei J, Seppala M, Viitala A, Liao Q. The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China. J Ther Ultrasound. 2016 Nov 3;4:27. doi: 10.1186/s40349-016-0072-9. eCollection 2016.
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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.
Qinping Liao principal investigator
Peking University First Hospital
Yueling Wang principal investigator
First Affiliated Hospital Xi'an Jiaotong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-HIFU uterine fibroid treatment in people with Uterine Fibroids, run by Philips Healthcare at 2 sites in China.
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 13 inclusion and 13 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 22 Oct 2015. 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 China. 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 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?
Change in fibroid volume (time frame: At baseline and at 6 months after treatment). The study lists 2 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 NCT01588899, 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 22 Oct 2015.