Clinical trial · Interventional
High Intensity Focused Ultrasound in Uterine Myoma
Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma
NCT03328260CI-TRIAL-00042575completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma
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 |
|---|---|---|---|
| Uterine Leiomyoma | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIFU | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- interventionNames
- Device: HIFU
Primary outcomes (1)
- measure
- Non perfused volume
- timeFrame
- treatment day
- description
- Non perfused volume in myoma immediately after ablation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal (FSH \< 40 IU/L) * Symptomatic uterine fibroids * Willing to contracept during study period Exclusion Criteria: * Pregnant or willing to be pregnant in future * Cancer in female reproductive organ is suspected or diagnosed * Inflammation in female reproductive organ * Poorly controlled systemic disease * Hematocrit \< 25% * Glomerular filtration rate(GFR) \<= 30ml/min * Cannot tolerate contrast-enhanced MR or Contrast-enhanced ultrasound(CEUS) * Cannot lie down * Previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks * Cannot count the number or measure volume of leiomyoma using MRI * Leiomyomas are inadequate (location, volume, number) for intervention * Diameter of leiomyoma is over 5 cm * Leiomyoma is not enhanced * Lactating women * Cannot communicate properly * Participating or have participated in other trials within 30 days
References
Publications (1)
- DERIVEDLee JY, Kim K, Hwang SI, Lee M, Son K, Kim D, Kim S, Kim YB. Efficacy and safety of transvaginal high-intensity focused ultrasound therapy in women with symptomatic uterine leiomyomas: A clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Jan;256:302-307. doi: 10.1016/j.ejogrb.2020.11.049. Epub 2020 Nov 17. PMID 33259999