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Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids

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What is being tested

UAE

+ HIFU

Procedure
Who is being recruted

Neoplasms+2

+ Neoplasms by Histologic Type

+ Neoplasms, Muscle Tissue

From 30 to 47 Years
+35 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2009
See protocol details

Summary

Principal SponsorChinese University of Hong Kong
Last updated: August 30, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01834703
Principal SponsorChinese University of Hong Kong
Last updated: August 30, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

85 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 30 to 47 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueLeiomyoma

Criteria

19 inclusion criteria required to participate
Age between 30 and 47
Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study
Cervical cytology no more severe than low grade SIL
Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 12 cm on imaging
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16 exclusion criteria prevent from participating
Contraindication to MRI due to severe claustrophobia or implanted metallic device
Desire for future pregnancy
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
Genetic causes of leiomyomata
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
After randomization, patient recruited will be arranged to receive UAE treatment. 100 patients will be recruited for UAE treatment

Group II

Active Comparator
After randomization, patient recruited will be arranged to receive HIFU treatment. 100 patients will be recruited for HIFU treatment

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong KongOpen Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong in Google Maps

Department of Obstectrics and Gynaecology, Prince of Wales Hospital

Hong Kong, Hong Kong
Suspended2 Study Centers