NL-OMON46077
Completed
Not Applicable
MRI based prognostic biomarkers for treatment success of Minimal invasive treatment for Uterine Fibroids with Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) - MASS II
Isala Klinieken0 sites75 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- leiomyoma
- Sponsor
- Isala Klinieken
- Enrollment
- 75
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with a symptomatic uterine fibroid (based on anamnesis, physical examination and vaginal ultrasonography), eligible for MR\-HIFU treatment.
Exclusion Criteria
- •\- Post menopausal patients
- •\- Pregnant patients
- •\- Calcified fibroids
- •\- Severe abdominal obesity
- •\- MRI contra indications
- •\- Funaki type 3 uterine fibroid
- •\- Uterine fibroid close to sciatic nerve of sacrum, interpostion of bowel or ovary.
- •\- Uterine fibroid diameter \< 1 cm or \> 10 cm
- •\- Distance skin \- uterine fibroid \> 10 cm
Outcomes
Primary Outcomes
Not specified
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