Safety & Efficacy of Non-Invasive Procedures Using Ultrasound-Guided HIFU 'Sonotrip V20' in Sympt… (NCT05972642) | Clinical Trial Compass
UnknownEarly Phase 1
Safety & Efficacy of Non-Invasive Procedures Using Ultrasound-Guided HIFU 'Sonotrip V20' in Symptomatic Uterine Fibroids
30 participantsStarted 2023-08-01
Plain-language 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. Participants will undergo the HIFU procedure based on a pre-established plan using MRI images. Assessments will be conducted immediately post-procedure and at 4 and 24 weeks. Primary endpoint is fibroid volume reduction at 24 weeks, with secondary endpoints including Non-Perfused Volume Ratio, quality of life, hemoglobin change, pain assessment, and additional medication use. Adverse events will be monitored.
Who can participate
Age range19 Years
SexFEMALE
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Inclusion criteria
✓. 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
✓. 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.
✓. 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
Exclusion criteria
✕. 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
✕. 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).
What they're measuring
1
Volume reduction
Timeframe: An independent imaging assessor will calculate the uterine fibroid volume on MR images taken at screening and 24 weeks post-procedure to assess the percentage reduction in uterine fibroid volume from screening to 24 weeks post-procedure.
. 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