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

NCT05972642 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-02

No results posted yet for this study

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

Interventions

DEVICE

HIFU-treatment

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.

Sponsors & Collaborators

  • Jeysis Medical

    collaborator UNKNOWN

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hee Seung Kim · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-08-01
Completion
2025-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05972642 on ClinicalTrials.gov