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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03328260

Enrollment

Registered

2017-11-01

Start date

2017-12-12

Completion date

2019-06-30

Last updated

2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Leiomyoma

Brief summary

Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma

Interventions

DEVICEHIFU

Transvaginal high intensity focused ultrasound to ablate uterine myoma

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Non perfused volume	treatment day	Non perfused volume in myoma immediately after ablation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026