Clinical trial NCT05972642: Safety & Efficacy of Non-Invasive Procedures Using Ultrasound-Guided HIFU 'Sonotrip V20' in Symptomatic Uterine Fibroids
Official title: A Prospective, Single Center, Single Group, Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Non-Invasive Procedures Using Ultrasound-Guided High-Intensity Focused Ultrasound 'Sonotrip V20'
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Myoma;Uterus
Keywords: Ultrasound-guided HIFU
Symptomatic uterine fibroids
Safety and efficacy
Sonotrip V20
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Jeysis Medical
First posted: 2023-08-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm study.
Primary purpose: TREATMENT

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. 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.

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) 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.

Eligibility criteria: Inclusion Criteria:

1. adult women 19 years of age or older
2. 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.
3. premenopausal (FSH\<40 mIU/ml)
4. 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).
5. have been diagnosed with fibroids by imaging studies.
6. have four or fewer fibroids to be treated
7. the size of the fibroids to be treated is 12 cm or less with no necrotic or calcified areas13
8. have voluntarily decided to participate in this study and have given written consent to the informed consent form and the study protocol
9. willing to comply with the protocol

Exclusion Criteria:

1. 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
2. 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.
3. 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).
4. 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.
5. 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)
6. the fibroids to be treated are not measurable on MRI
7. the location of the fibroids to be treated falls into type 7 and/or type 8 according to the following classification

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: NPVR
timeFrame: within 24 hours of the procedure
measure: Quality of life-SF36
timeFrame: Evaluate changes in quality of life before and after 4 weeks and 24 weeks after procedure
measure: Quality of life-UFS-QOL
timeFrame: Evaluate changes in quality of life before and after 4 weeks and 24 weeks after procedure
measure: Hct change
timeFrame: Evaluate the rate of change in hemoglobin (Hb) from pre-procedure to 4 and 24 weeks post-procedure.
measure: Intra-procedural pain assessment
timeFrame: During the time of procedure
measure: Percentage of subjects who received additional sedation or pain medication (N%)
timeFrame: During and after the procedure within 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim
role: PRINCIPAL_INVESTIGATOR
References: