Uterine FibroidsPhase 1MRgHIFUNCT02283502
Clinical Test of the MRgHIFU System on Uterine Fibroids
A Phase 1 study testing MRgHIFU system in people with Uterine Fibroids, run by Chin-Jung Wang at 1 site in Taiwan.
Trial summary
The objectives of this program are to verify the safety and effectiveness of the MRgHIFU system developed by the division of Medical Engineering of National Health Research Institutes (NHRI) Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- MRgHIFU system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2014to May 2015
- Phase
- Phase 1
- 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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Already sign in the Informed Consent Form。
- The woman who want to operate the Hysteromyomectomy, and the volume of the fibromyoma is between 5-10 cm, will be included。
- Woman age between 35~45 years, and do not want to be pregnant
- Abdominal circumference≦95 ㎝.
- No pregnant.
- MRI compatible.
Who cannot join
- Pregnant or Breast-feeding.
- MRI uncompatible.
- Woman who has scar in Abdomen.
- Immunodeficiency or cancer.
- Use the clinical medicine before 3 month age.
- The woman who will not follow the project. -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Clinical Trial Center
Taoyuan, Taiwan, 333
About this study
Official title: For Research Purpose the Clinical Test of the Magnetic Resonance Imaging Guided Focused Ultrasound Ablation System on Uterine Fibroids
The objectives of this program are to verify the safety and effectiveness of the MRgHIFU system developed by the division of Medical Engineering of National Health Research Institutes (NHRI)
Read the detailed description
Between 25 % - 50 % of women of childbearing age have uterine fibroids. Also, 25% of women with fibroids suffer from the metrorrhagia, menorrhagia, dysmenorrheal or pelvic compression so that they don't have a good quality of life. The worse case is the fertility of patients with fibroids is hindered. The current clinical treatment is medication or surgery. Medication can only suppress the symptom temporarily when the hysterectomy method of removing part or all of uterus can cure the patient completely. However, the hysterectomy is an invasive operation and the women with fibroids who plan to have a baby don't accept this kind of treatment.
Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids has been developed and was approved by the US Food and Drug Administration (FDA) in 2004. The ultrasound waves emitted by the ultrasonic probe propagate through the skin, fat, muscle, soft tissues and converge on fibroids at focus. High energy/intensity at focus causes the thermal necrosis of the fibroid tissue in several seconds. The whole process of HIFU ablation of fibroids is monitored and guided by MR thermometery. The advantage of MR-HIFU modality includes no incision, outpatient treatment and few side effects.
The objectives of this program are to verify the safety and effectiveness of the MRgHIFU system developed by the division of Medical Engineering of National Health Research Institutes (NHRI), to achieve the clinical trial at the Chang-Gung Memorial Hospitals of Linkou and to commercialize the self-developed MRgHIFU system. The mission is to conduct the first-stage clinical test for 10 women with symptomatic uterine fibroids and to make two sets of HIFU system. Meanwhile, the impact of quality of life and satisfaction with treatment of the patients diagnosed with symptomatic uterine fibroids will be analyzed.
- Conditions
- Uterine Fibroids
- Being tested
- MRgHIFU system
- Keywords
- Uterine fibroid, magnetic resonance imaging, ultrasound, non-invasive therapy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRgHIFU systemDevice
Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids
| Study group | Role | What they receive |
|---|---|---|
| Intervention: MRgHIFU, Surgery | Experimental | Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids Receives: Device: MRgHIFU system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Check Adverse Event or Serious Adverse Event
follow up
Measured: six month
Secondary outcomes (2)
Using MRI to confirm the volume of the fibromyoma.
follow up difference of fibromyoma that before and after treatment
Measured: Screen, after treatment 1Month, 3Month, 6Month
Using quality of life questionnaire to compare quality of life that before and after treatment
follow up
Measured: Screen, after treatment 1Month, 3Month, 6Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chin-Jung Wang
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor-investigator, Chin-Jung Wang, Chang Gung Memorial Hospital
- Investigators
- Chin-Jung Wang, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283502
- Sponsor's protocol ID
- NHRI-CTC-067
- Acronym
- MRgHIFU
- Status last verified
- Oct 2014
- First submitted
- 28 Oct 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- For Research Purpose the Clinical Test of the Magnetic Resonance Imaging Guided Focused Ultrasound Ablation System on Uterine Fibroids
- ClinicalTrials.gov ID
- NCT02283502
- Acronym / sponsor ID
- MRgHIFU / NHRI-CTC-067
- Conditions
- Uterine Fibroids
- Keywords
- Uterine fibroid, magnetic resonance imaging, ultrasound, non-invasive therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chin-Jung WangUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Sep 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 5 Nov 2014 (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 objectives of this program are to verify the safety and effectiveness of the MRgHIFU system developed by the division of Medical Engineering of National Health Research Institutes (NHRI)
Detailed description
Between 25 % - 50 % of women of childbearing age have uterine fibroids. Also, 25% of women with fibroids suffer from the metrorrhagia, menorrhagia, dysmenorrheal or pelvic compression so that they don't have a good quality of life. The worse case is the fertility of patients with fibroids is hindered. The current clinical treatment is medication or surgery. Medication can only suppress the symptom temporarily when the hysterectomy method of removing part or all of uterus can cure the patient completely. However, the hysterectomy is an invasive operation and the women with fibroids who plan to have a baby don't accept this kind of treatment.
Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids has been developed and was approved by the US Food and Drug Administration (FDA) in 2004. The ultrasound waves emitted by the ultrasonic probe propagate through the skin, fat, muscle, soft tissues and converge on fibroids at focus. High energy/intensity at focus causes the thermal necrosis of the fibroid tissue in several seconds. The whole process of HIFU ablation of fibroids is monitored and guided by MR thermometery. The advantage of MR-HIFU modality includes no incision, outpatient treatment and few side effects.
The objectives of this program are to verify the safety and effectiveness of the MRgHIFU system developed by the division of Medical Engineering of National Health Research Institutes (NHRI), to achieve the clinical trial at the Chang-Gung Memorial Hospitals of Linkou and to commercialize the self-developed MRgHIFU system. The mission is to conduct the first-stage clinical test for 10 women with symptomatic uterine fibroids and to make two sets of HIFU system. Meanwhile, the impact of quality of life and satisfaction with treatment of the patients diagnosed with symptomatic uterine fibroids will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: MRgHIFU, Surgery | Experimental | Device: MRgHIFU systemMagnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Already sign in the Informed Consent Form。
- The woman who want to operate the Hysteromyomectomy, and the volume of the fibromyoma is between 5-10 cm, will be included。
- Woman age between 35~45 years, and do not want to be pregnant
- Abdominal circumference≦95 ㎝.
- No pregnant.
Key exclusion criteria (6 listed)
- Pregnant or Breast-feeding.
- MRI uncompatible.
- Woman who has scar in Abdomen.
- Immunodeficiency or cancer.
- Use the clinical medicine before 3 month age.
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 |
|---|---|---|
| MRgHIFU systemMagnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids | Device | Intervention: MRgHIFU, Surgery |
Primary outcome
Check Adverse Event or Serious Adverse Event
Time frame: six month
follow up
2 secondary outcomes
Using MRI to confirm the volume of the fibromyoma.
Time frame: Screen, after treatment 1Month, 3Month, 6Month
Using quality of life questionnaire to compare quality of life that before and after treatment
Time frame: Screen, after treatment 1Month, 3Month, 6Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
Chin-Jung Wang, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRgHIFU system in people with Uterine Fibroids, run by Chin-Jung Wang at 1 site 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 6 inclusion and 6 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 Nov 2014. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chin-Jung Wang, MD (886-3-3281200 ext. 8251, wang2260@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Check Adverse Event or Serious Adverse Event (time frame: six month). 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 Nov 2014.