High Intensity Focused Ultrasound in Uterine Myoma

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

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Key information

Conditions

Uterine Leiomyoma Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyenggi DO, 463707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIFU

Device

Transvaginal high intensity focused ultrasound to ablate uterine myoma

Primary outcomes

Non perfused volume

Time frame: treatment day

Non perfused volume in myoma immediately after ablation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

ALPINION Medical Systems

Registry information

Official study title

Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Nov 1, 2017
Registry last updated: Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed