Clinical trial · Interventional
High-intensity Focused Ultrasound in Treatment of Uterine Fibroid
Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Fibroid
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Uterine fibroids are common uterine benign neoplasm. They can cause abnormal menstrual bleeding, pelvic discomfort and urinary frequency. Although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU) therapy is receiving increasing interest in the management of uterine fibroids by inducing focal thermocoagulation of the fibroids. Results obtained by various research groups have shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of uterine fibroids. In this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study inclusion criteria will be invited to participate in the study which involves the use of HIFU in the management of the fibroid. Background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. Subjects will also be asked to complete an eight-item section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) which evaluate the effect of the fibroid on the quality of life of women.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroids | Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIFU treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- HIFU treatment
- interventionNames
- Procedure: HIFU treatment
Primary outcomes (1)
- measure
- Efficacy of HIFU in reducing the size of the uterine fibroids by sonographic measurements
- timeFrame
- The changes from baseline to post12-month treatment will be captured
- description
- By sonographic measurements at baseline, post 1-month, post 3-month, and post 12-month, the size of the uterine fibroids will be evaluated by physicians
Secondary outcomes (5)
- measure
- Patient satisfaction score after HIFU treatment of uterine fibroid
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>40 years old, with no future childbearing plans * Age \>30 years old, who has tubal sterilization * Significant fibroids symptoms * Clinical uterine size less than 20 weeks gestation * Dominant fibroid less than 10 cm in diameter without areas of necrosis as judged by contrast MRI * No laparotomy scars * Women should be able to give consent Exclusion Criteria: * Other pelvic or uncontrolled systemic diseases * Confirmed or suspected pregnancy * Patients who are contraindicated for MRI examination * Patients with thick abdominal wall (\>5 cm, as measured by MRI) * Presence or history of acute pelvic inflammatory disease * History of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion * Cervical fibroids, subserous or submucous fibroids with pedicle, \<3.5 cm posterior wall fibroid, fibroids suspicious of malignancy (rapidly growing)
References
Publications (0)
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