Status:
UNKNOWN
Safety & Efficacy of Non-Invasive Procedures Using Ultrasound-Guided HIFU 'Sonotrip V20' in Symptomatic Uterine Fibroids
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Jeysis Medical
Conditions:
Myoma;Uterus
Eligibility:
FEMALE
19+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a single-arm clinical trial evaluating the safety and efficacy of ultrasound-guided HIFU (Sonotrip V20) for symptomatic uterine fibroids. 57 cases will be enrolled at a Korean institution. Par...
Detailed Description
This study is designed as a prospective, single-center, single-arm, confirmatory clinical trial to evaluate the safety and efficacy of the ultrasound-guided High-Intensity Focused Ultrasound (HIFU) de...
Eligibility Criteria
Inclusion
- adult women 19 years of age or older
- with symptomatic uterine fibroids\* (e.g., heavy periods, dysmenorrhea, abnormal bleeding, pressure symptoms including pelvic pain, and urinary and bowel dysfunction)12
- \*Symptomatic fibroids: a Symptom Severity Score (SSS) score of 41 or higher on the UFS-QOL questionnaire for fibroid symptoms.
- premenopausal (FSH\<40 mIU/ml)
- For women of childbearing potential, agree to use at least one clinically adequate method of contraception\* for the duration of the study.
- \* Clinically adequate contraception is defined as "\[intrauterine device (e.g., Loop, Mirena), chemical barrier method (spermicide), or subdermal implant (e.g., Implanon)\] + physical barrier method (male or female)", tubal surgery, or laparoscopic contraception (a type of tubal ligation).
- have been diagnosed with fibroids by imaging studies.
- have four or fewer fibroids to be treated
- the size of the fibroids to be treated is 12 cm or less with no necrotic or calcified areas13
- have voluntarily decided to participate in this study and have given written consent to the informed consent form and the study protocol
- willing to comply with the protocol
Exclusion
- suspected intrauterine malignancy on contrast MR scan (however, if endometrial biopsy confirms that the lesion is not malignant, the patient may be eligible to participate in the study)14, 15, 16
- the lesion to be treated is adenomyosis or highly perfused fibroid\*17
- \*highly perfused fibroid is defined as having an image intensity equal to or greater than the myometrium on T2-weighted images.
- Planning to become pregnant in the future, or currently pregnant (women of childbearing potential who are β-hCG positive are not eligible to participate in the study).
- Have a contraindication to MRI examination (e.g., claustrophobia) or a history of hypersensitivity to gadolinium-based contrast agents (MR contrast agents) or ultrasound contrast agents However, if any of the above can be controlled with medication, patients may be eligible to participate in the study.
- currently being treated with or having been treated with gonadotropin-releasing hormone agonists (GnRHa) (however, if 12 weeks have elapsed since the end of GnRHa treatment, patients may participate in the study)
- the fibroids to be treated are not measurable on MRI
- the location of the fibroids to be treated falls into type 7 and/or type 8 according to the following classification
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05972642
Start Date
August 1 2023
End Date
December 1 2025
Last Update
August 2 2023
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