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Clinical Trials/NL-OMON35027
NL-OMON35027
Withdrawn
Not Applicable

Minimal Invasive versus Non Invasive treatment for symptomatic uterine fibroids: A randomized controlled trial comparing uterine artery embolization with magnetic resonance guided focused ultrasound (MINI TRIAL) - MINI TRIA

niversitair Medisch Centrum Utrecht0 sites74 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
74
Status
Withdrawn
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •\-Minimum age of 18 years
  • •\-Patient is pre\- or peri\-menopausal
  • •\-Diagnosis of uterine fibroids is confirmed with MRI
  • •\-Patient suffers from symptomatic uterine fibroids (defined as a minimum Symptom Severity Score of 40 points)
  • •\-Patient must provide written informed consent

Exclusion Criteria

  • •\-Uterine size larger than 24 weeks of gestation
  • •\-Dominant fibroid \< 3 cm or \> 12 cm diameter
  • •\-Pedunculated uterine fibroids with a stalk diameter less than one third of the fibroid diameter (MRI)
  • •\-Current pregnancy or desire for future pregnancy
  • •\-Suspected gynaecologic malignancy
  • •\-Extensive scarring along anterior lower abdominal wall
  • •\-Scar tissue or surgical clips in the direct path of the FUS beam
  • •\-Current gynaecologic infection
  • •\-Presence of intra uterine device
  • •\-Degenerated or calcified fibroids (evidenced by gadolinium non\-enhancement on MRI)

Outcomes

Primary Outcomes

Not specified

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