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Clinical Trials/NL-OMON46077
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Isala Klinieken

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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