Posted in Fibroid Relief News

New Clinical Trial with Focused Ultrasound and Fibroids (Europe & Asia)

Posted in Fibroid Relief News

Recently a new posting popped up on ClinicalTrials.gov for Focused Ultrasound and Uterine Fibroids.  This study is recruiting patients (estimated at 24) in France, Germany, the Republic of Korea and the Netherlands.  Eligibility and Criteria are listed below and more information can be found by clicking here.

Eligibility

Ages Eligible for Study: 18 Years to 59 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Women, age between 18 and 59 years
  • Weight < 140kg
  • Pre- or peri-menopausal
  • Uterine size < 24 weeks
  • Transformed SSS score > 40
  • Normal Cervical cell assessment by PAP
  • Symptomatic Fibroid disease
  • Dominant fibroid greater than or equal to 3cm and less than or equal to 12 cm

Exclusion Criteria:

  • Other Pelvic Disease
  • Desire for future pregnancy
  • Significant systemic disease even if controlled
  • Positive pregnancy test
  • Hematocrit < 25%
  • Scarring or other interference of the HIFU beam
  • MRI or contrast contraindicated
  • Fibroids not quantifiable on MRI
  • Calcifications around or throughout uterine tissues
  • Communication barrier
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