Uterine FibroidsNCT01834703
Uterine Artery Embolization(UAE) Versus High-Intensity-Focused-Ultrasound(HIFU) for Treatment of Uterine Fibroids
A study testing UAE and HIFU in people with Uterine Fibroids, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
This study aimed to evaluate the clinical effectiveness and adverse effects of Uterine Artery Embolization (UAE), High-Intensity-Focused-Ultrasound (HIFU) in treating patients with uterine fibroid. Read more about this study
- Who is it for?
- Ages 30 to 47 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- UAE and HIFU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesHong Kong
- Study dates
- May 2009to Dec 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 30 to 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female gender
- Age between 30 and 47
- Pre or peri menopausal with Follicle-stimulating hormone (FSH) less than 40 mIU/ml
- Weight less than 140kg (or 310lbs) and Body Mass Index (BMI) less than 33
- Cervical cytology no more severe than low grade SIL
- Negative urine pregnancy test
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- Uterine size less than 24 weeks based on physical exam assessment
- History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain. Excessive uterine bleeding will be evidenced by either one of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss OR pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection
- Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 12 cm on imaging.
- Good health other than history of leiomyomas. Chronic medications may be acceptable at the discretion of the research team.
- No future fertility wish.
- Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study.
- Willing and able to give informed consent.
- Willing and able to comply with study requirements.
- Normal menstrual cycle with endometrial pathology excluded
- Normal renal function
- Normal liver function
- Platelet count greater than 50 K/microL
- Normal coagulation profile
Who cannot join
- Significant abnormalities in the history, physical or laboratory examination
- History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
- Other pelvic mass indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease
- Desire for future pregnancy
- Pregnant or Positive pregnancy test
- Lactation
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- Unexplained vaginal bleeding
- Untreated severe cervical dysplasia
- Intrauterine device
- Need for interval use of narcotics
- Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or scar tissue or surgical clips in the direct path of the HIFU
- Pedunculated submucosal or subserosal fibroid of size ≧5cm and with a stalk less than 25% of the maximal fibroid diameter.
- Genetic causes of leiomyomata
- Known recent rapid growth of fibroids, defined as a doubling in size in 6 months
- Patient unwilling to receive non-surgical treatment
- Contraindication to MRI due to severe claustrophobia or implanted metallic device.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Department of Obstectrics and Gynaecology, Prince of Wales Hospital
Hong Kong
About this study
Official title: Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids
This study aimed to evaluate the clinical effectiveness and adverse effects of Uterine Artery Embolization (UAE), High-Intensity-Focused-Ultrasound (HIFU) in treating patients with uterine fibroid.
Read the detailed description
The usual management for symptomatic uterine fibroid is surgery (myomectomy or hysterectomy), in the current study, uterine artery embolization (UAE) is a form of non-surgical and minimally invasive treatment, High-Intensity-Focused-Ultrasound (HIFU) is a form of non-invasive treatment that can be completed as an out-patient within hours. Embolization causes ischaemia and shrinkage of the fibroid and therefore symptomatic relieve. HIFU is a medical technology that has been used for cancer treatment. Energy is delivered from outside the body in a non-invasive manner to produce heat energy that causes necrosis and shrinkage of the uterine fibroid thereby relieves the symptoms due to the fibroid. It does not involve radiation. The clinical effectiveness of HIFU for uterine fibroid is unknown, however, based on the knowledge of the clinical effectiveness of HIFU on liver cancer and pancreatic cancer, there is reasonable ground to believe that HIFU is effective for uterine fibroid.
- Conditions
- Uterine Fibroids
- Being tested
- UAE, HIFU
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UAEProcedure or surgery
The patient will be admitted into hospital for UAE. UAE was performed with patients under local anesthesia. Embosphere particles (BioSphere Medical) with a size of 500 - 700µm were used in all procedures. Embospheres were mixed with contrast material and saline and injected into each uterine artery until either parenchyma filling of the fibroids had stopped (target embolization) or the main uterine artery was blocked with stasis of contrast material (selective embolization). After the procedure, women were admitted to the gynecology ward for postprocedural care. All patients were advised to stay in the hospital for at least 1 night.
HIFUProcedure or surgery
Treatment will be given to the patient in one or more sessions on an outpatient basis. The uterine fibroid will be identified and located with ultrasonography and ablated with HIFU. For lesion beyond 6 cm distance from skin, HIFU is given at a power of 1200-1500 watt for 1500 - 2000 times at each spot, for 50 milli-second each time, at an interval of 100 milli-second, at a spot distance of 1.5cm, a line distance of 1.5cm, and a plane distance of 1.0 -1.5cm; for lesion within 6 cm distance from skin, HIFU is given at a power of 1300±15% Watt for 40 times at each spot, for120 milli-second each time, at an interval of 100 milli-second, at a spot distance of 0.3cm, a line distance of 0.3cm, and a plane distance of 0.8cm.
| Study group | Role | What they receive |
|---|---|---|
| UAE treatment | Active comparator | After randomization, patient recruited will be arranged to receive UAE treatment. 100 patients will be recruited for UAE treatment Receives: Procedure: UAE |
| HIFU | Active comparator | After randomization, patient recruited will be arranged to receive HIFU treatment. 100 patients will be recruited for HIFU treatment Receives: Procedure: HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate
Technical success of treatment procedure and absence of symptoms of fibroid
Measured: 6 months
Secondary outcomes (4)
Incidence of procedure related complication
Complications after treatment procedures will be recorded during each hospital admission and during each HIFU treatment session. Major adverse events will be reported. Complications that occur prior to a clinical visit will be documented and graded in each clinical visit at 1, 3, 6 and 12 month after treatment.
Measured: 1, 3, 6, 12 months after treatment
volume change of the fibroids
Assessed by 3 Dimensional ultrasonography (USG)
Measured: 6, 12 months after treatment
Degree of infarction of the fibroids
Contrast enhanced magnetic resonance imaging (MRI) is used to assess the degree of infarction, which is defined as non-perfused tissue on contrast MRI.
Measured: 3, 15 months after treatment
Vascularity of the fibroids
Assessed by contrast enhanced USG. Vascularity of the fibroid will be classified into six categories: 0%, <25%, 25 to 50%, >50 to 75%, >75%, 100%.
Measured: 6, 12 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 posted18 Apr 2013 (estimated)
- Study startMay 2009
- Primary completionDec 2015
- Study completionDec 2015
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.
- More trials run by Chinese University of Hong KongThe 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
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong
- Responsible party
- Principal investigator, Simon Yu, Chinese University of Hong Kong
- Investigators
- Simon CH Yu, MD, FRCR, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834703
- Sponsor's protocol ID
- VIR-13-02
- Status last verified
- Feb 2016
- First submitted
- 4 Apr 2013
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids
- ClinicalTrials.gov ID
- NCT01834703
- Acronym / sponsor ID
- VIR-13-02
- Conditions
- Uterine Fibroids
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong
- Study start
- May 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (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.
This study aimed to evaluate the clinical effectiveness and adverse effects of Uterine Artery Embolization (UAE), High-Intensity-Focused-Ultrasound (HIFU) in treating patients with uterine fibroid.
Detailed description
The usual management for symptomatic uterine fibroid is surgery (myomectomy or hysterectomy), in the current study, uterine artery embolization (UAE) is a form of non-surgical and minimally invasive treatment, High-Intensity-Focused-Ultrasound (HIFU) is a form of non-invasive treatment that can be completed as an out-patient within hours. Embolization causes ischaemia and shrinkage of the fibroid and therefore symptomatic relieve. HIFU is a medical technology that has been used for cancer treatment. Energy is delivered from outside the body in a non-invasive manner to produce heat energy that causes necrosis and shrinkage of the uterine fibroid thereby relieves the symptoms due to the fibroid. It does not involve radiation. The clinical effectiveness of HIFU for uterine fibroid is unknown, however, based on the knowledge of the clinical effectiveness of HIFU on liver cancer and pancreatic cancer, there is reasonable ground to believe that HIFU is effective for uterine fibroid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UAE treatment | Active comparator | Procedure: UAEAfter randomization, patient recruited will be arranged to receive UAE treatment. 100 patients will be recruited for UAE treatment |
| HIFU | Active comparator | Procedure: HIFUAfter randomization, patient recruited will be arranged to receive HIFU treatment. 100 patients will be recruited for HIFU treatment |
Who may qualify
- Ages
- 30 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Female gender
- Age between 30 and 47
- Pre or peri menopausal with Follicle-stimulating hormone (FSH) less than 40 mIU/ml
- Weight less than 140kg (or 310lbs) and Body Mass Index (BMI) less than 33
- Cervical cytology no more severe than low grade SIL
Key exclusion criteria (16 listed)
- Significant abnormalities in the history, physical or laboratory examination
- History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
- Other pelvic mass indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease
- Desire for future pregnancy
- Pregnant or Positive pregnancy test
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 |
|---|---|---|
| UAEThe patient will be admitted into hospital for UAE. UAE was performed with patients under local anesthesia. Embosphere particles (BioSphere Medical) with a size of 500 - 700µm were used in all procedures. Embospheres were mixed with contrast material and saline and injected into each uterine artery until either parenchyma filling of the fibroids had stopped (target embolization) or the main uterine artery was blocked with stasis of contrast material (selective embolization). After the procedure, women were admitted to the gynecology ward for postprocedural care. All patients were advised to stay in the hospital for at least 1 night. | Procedure or surgery | UAE treatment |
| HIFUTreatment will be given to the patient in one or more sessions on an outpatient basis. The uterine fibroid will be identified and located with ultrasonography and ablated with HIFU. For lesion beyond 6 cm distance from skin, HIFU is given at a power of 1200-1500 watt for 1500 - 2000 times at each spot, for 50 milli-second each time, at an interval of 100 milli-second, at a spot distance of 1.5cm, a line distance of 1.5cm, and a plane distance of 1.0 -1.5cm; for lesion within 6 cm distance from skin, HIFU is given at a power of 1300±15% Watt for 40 times at each spot, for120 milli-second each time, at an interval of 100 milli-second, at a spot distance of 0.3cm, a line distance of 0.3cm, and a plane distance of 0.8cm. | Procedure or surgery | HIFU |
Primary outcome
Treatment success rate
Time frame: 6 months
Technical success of treatment procedure and absence of symptoms of fibroid
4 secondary outcomes
Incidence of procedure related complication
Time frame: 1, 3, 6, 12 months after treatment
volume change of the fibroids
Time frame: 6, 12 months after treatment
Degree of infarction of the fibroids
Time frame: 3, 15 months after treatment
Vascularity of the fibroids
Time frame: 6, 12 months after treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Simon CH Yu, MD, FRCR principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UAE and HIFU in people with Uterine Fibroids, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 19 inclusion and 16 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: stopped early, as of the sponsor's last update on 30 Aug 2019. 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 Hong Kong. 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. 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?
Treatment success rate (time frame: 6 months). 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 30 Aug 2019.