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

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

August 1, 2025

Study Completion Date

December 1, 2025

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 (1)

All Listed Sponsors
collaborator

Jeysis Medical

UNKNOWN

lead

Seoul National University Hospital

OTHER

NCT05972642 - Safety & Efficacy of Non-Invasive Procedures Using Ultrasound-Guided HIFU 'Sonotrip V20' in Symptomatic Uterine Fibroids | Biotech Hunter | Biotech Hunter