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Clinical Trials/DRKS00013526
DRKS00013526
Recruiting
N/A

Evaluation of suitable criteria for the therapy of uterine fibroids by MR-guided high-intensity focused ultrasound (MR-HIFU) - HIFU-Myom

Klinikum der Universität München, Campus Großhadern0 sites75 target enrollmentMay 25, 2018
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ConditionsD25.0D25.1Submucous leiomyoma of uterusIntramural leiomyoma of uterus

Overview

Phase
N/A
Intervention
Not specified
Conditions
D25.0
Sponsor
Klinikum der Universität München, Campus Großhadern
Enrollment
75
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 25, 2018
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Klinikum der Universität München, Campus Großhadern

Eligibility Criteria

Inclusion Criteria

  • •1\. Age of at least 18 years.
  • •2\. Current creatinine
  • •3\. Indication for local ablative therapy by means of HIFU
  • •4\. Accessibility of the fibroid / fibroids with HIFU
  • •5\. Funaki Type I\-II
  • •6\. Signed declaration of consent with compliance incl. Follow\-up treatment with compliance including follow\-up treatment
  • •7\. Size of fibroid \<12 cm
  • •8\. Exclusion of a leiomyosarcoma
  • •9\. Signed declaration of consent

Exclusion Criteria

  • •1\. Taking Ulipristalacetat (Esmya) over the past 6 months
  • •2\. General MRI contraindications (pacemakers, metal parts)
  • •3\. contrast agent allergy
  • •4\. Significantly reduced general condition
  • •5\. Massive obesity (BMI\> 40\)
  • •6\. Patients with mental / psychiatric disorders
  • •7\. pregnancy
  • •8\. intrauterine Device
  • •9\. Funaki Type III\-IV
  • •10\. Pedunculated serous fibroid

Outcomes

Primary Outcomes

Not specified

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