Safety & Efficacy of Non-Invasive Procedures Using Ultrasound-Guided HIFU 'Sonotrip V20' in Symptomatic Uterine Fibroids

NCT05972642 | Unknown Early Phase 1

• 1 other identifier: HIFU-PCT
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myoma;Uterus

Keywords

Ultrasound-guided HIFU; Symptomatic uterine fibroids; Safety and efficacy; Sonotrip V20

Outcome Measures

Primary Outcomes (1)

• Volume reduction

  Uterine fibroid volume reduction at 24 weeks post-procedure (%)

  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 (6)

• NPVR

  within 24 hours of the procedure

• Quality of life-SF36

  Evaluate changes in quality of life before and after 4 weeks and 24 weeks after procedure

• Quality of life-UFS-QOL

  Evaluate changes in quality of life before and after 4 weeks and 24 weeks after procedure

• Hct change

  Evaluate the rate of change in hemoglobin (Hb) from pre-procedure to 4 and 24 weeks post-procedure.

• Intra-procedural pain assessment

  During the time of procedure

Study Arms (1)

HIFU treatment

EXPERIMENTAL

Eligible patients will be treated with HIFU instrument.

Device: HIFU-treatment

Interventions

HIFU-treatment DEVICE

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.

Also known as: Treatment arm

HIFU treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Jeysis Medical: collaborator

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hee Seung Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Seung Kim, MD/PhD

CONTACT

82-2-3668-7419; bboddi0311@snu.ac.kr

Soo Jin Park

CONTACT

soojin.mdpark@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: As this is a single-arm study, there will be no separate randomization and blinding procedures. However, to minimize bias to the efficacy assessor, an imaging assessor independent of the investigator will be assigned to assess the percentage reduction in uterine fibroid volume. The independent assessor will use MR imaging to assess the volume of the uterine fibroids at screening versus the volume of the uterine fibroids at 24 weeks post-procedure and the volume of the nonperfused area immediately post-procedure. In addition, the independent assessor's assessment notes will be kept secure for the duration of the study and will not be accessible to anyone other than the independent assessor. Once all assessments are completed for a subject, they will be forwarded to the Data Controller in batches.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm study.

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: August 2, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 2, 2023

Record last verified: 2023-07