Trials / Active Not Recruiting
Active Not RecruitingNCT03948789
Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy
Multicenter, Randomized Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids (MRgFUS TUF) Compared to Myomectomy in Symptomatic Medication and Not Sufficiently Treatable Uterine Fibroids
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 127 (estimated)
- Sponsor
- Krankenhaus Nordwest · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2020-07-15
- Primary completion
- 2025-09-01
- Completion
- 2025-10-01
- First posted
- 2019-05-14
- Last updated
- 2024-11-13
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03948789. Inclusion in this directory is not an endorsement.