High Intensity Focused Ultrasound in Uterine Myoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-12

Study Completion Date

2019-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Uterine Leiomyoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

HIFU

Intervention Type DEVICE

Transvaginal high intensity focused ultrasound to ablate uterine myoma

Interventions

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HIFU

Transvaginal high intensity focused ultrasound to ablate uterine myoma

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No