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.
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) device 'Sonotrip V20' in patients with symptomatic uterine fibroids, and includes a total of 57 cases (considering a dropout rate of 20%) at one institution in Korea. After receiving a full explanation of the study, volunteers who voluntarily agree in writing to participate in this study and are found to meet the inclusion/exclusion criteria will be enrolled in the study, assigned a subject registration number, and scheduled for hospitalization and procedure. The investigator will develop a procedure plan from the MRI images prior to the procedure date and perform the HIFU procedure according to the pre-established procedure plan on the day of the procedure. Subjects will undergo observations and tests (such as pregnancy tests and laboratory tests) to evaluate efficacy and safety immediately after the procedure and at 4 and 24 weeks after the procedure. The primary efficacy endpoint to evaluate the safety and efficacy of the investigational medical device is "reduction in uterine fibroid volume (%) at 24 weeks post-procedure," and the secondary efficacy endpoints are "Non-Perfused Volume Ratio (NPVR) immediately after the procedure," "quality of life (score)," "post-procedure hemoglobin change (%)," "pain assessment during the procedure (score)," and "percentage of subjects receiving additional sedation or pain medication (N%). Safety is assessed by the number of adverse events that occurred in subjects during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The investigator will sedate the subject and perform the HIFU procedure with the investigational medical device according to the pre-established procedure plan (see Table 11 for procedure plan) (procedure may take up to 2 hours). During the procedure, the investigator may modify the pre-established procedure plan by checking in with the subject occasionally to assess the presence of heat and pain at the site of the investigational device application.
Volume reduction
Uterine fibroid volume reduction at 24 weeks post-procedure (%)
Time frame: 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.
NPVR
An independent imaging assessor will evaluate the ratio of the volume of the uterine fibroids at screening to the volume of the nonperfused area immediately after the procedure (within 24 hours of the procedure) using MR imaging. Percentage of the volume of non-perfused tissue (tissue that is not enhanced on contrast MR imaging because it is necrotic and not flowing with blood from the HIFU procedure) by volume of uterine fibroids.
Time frame: within 24 hours of the procedure
Quality of life-SF36
It is a questionnaire for assessing overall quality of life and consists of 36 questions in eight domains: physical functioning, role limitation-physical, bodily pain, general health, vitality, social functioning, role limitation-emotional, mental health, and other health status change questions.
Time frame: Evaluate changes in quality of life before and after 4 weeks and 24 weeks after procedure
Quality of life-UFS-QOL
This questionnaire is designed to assess quality of life related to uterine fibroid symptoms and consists of an 8-item Symptom Severity Score and a 29-item Quality of Life Questionnaire.
Time frame: Evaluate changes in quality of life before and after 4 weeks and 24 weeks after procedure
Hct change
Post-procedure hemoglobin change (%)
Time frame: Evaluate the rate of change in hemoglobin (Hb) from pre-procedure to 4 and 24 weeks post-procedure.
Intra-procedural pain assessment
After the procedure, a self-completed Numerical Rating Scale (NRS), 0-10 questionnaire will be used to assess pain from the HIFU procedure during the procedure.
Time frame: During the time of procedure
Percentage of subjects who received additional sedation or pain medication (N%)
Evaluate the percentage of subjects who received additional sedation or analgesia during the procedure and within 24 hours after the procedure.
Time frame: During and after the procedure within 24 hours
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