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Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy

NCT03948789 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2024-11-13

No results posted yet for this study

Summary

The aim of the study is to answer the question, whether in patients with symptomatic and medically not sufficiently treatable uterine fibroids (population) the "Magnetic-Resonance-Guided Focused Ultrasound Surgery" short, MRgFUS-TUF (intervention) offers less burdensome therapy and patient-relevant advantages (symptom relief) compared to the operative myomectomy (comparison). The study will hence investigate the therapeutic benefit of this method.

Conditions

  • Uterine Fibroids

Interventions

PROCEDURE

Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy

Magnetic Resonance Imaging-controlled high-focussed ultrasound

PROCEDURE

Myomectomy (laparoscopic or open surgical)

Myomectomy (laparoscopic or open surgical)

Sponsors & Collaborators

  • Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Thorsten O Götze, PD Dr. med. · Krankenhaus Nordwest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2025-09-30
Completion
2025-10-31

Countries

  • Germany

Study Locations

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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 NCT03948789 on ClinicalTrials.gov