The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.
DUAO is intended for bilateral occlusion of the uterine arteries
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
For bilateral occlusion of the uterine arteries
Viborg County Hospital
Viborg, Denmark
University Hospital
Angers, France
Service de Gynecologie Obsterique, Hopital Antoine Beclere
Clamart, France
Lack of surgical re-intervention
Time frame: Post-op through end of study
Percentage of subjects with improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity and Health Related Quality of Life (HRQL) scores.
Time frame: 6, 12 and 24 months
Mean improvement in UFS-QOL Symptom Severity and HRQL transformed scores.
Time frame: 6, 12 and 24 months
Mean HRQL subscales.
Time frame: 6, 12 and 24 months
Percentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score.
Time frame: 6 and 12 months
Mean change in PBLAC scores.
Time frame: Baseline to 6 and 12 months
Percentage of subjects with decrease in fibroid load based on independent MRI review.
Time frame: 6 months
Percentage of subjects with maintenance of menses as defined by continuation of menstrual cycles without an interruption of three consecutive months
Time frame: 12 months
Percentage of subjects with procedural satisfaction as defined by responses of either satisfied or very satisfied.
Time frame: 12 months
Lack of surgical re-intervention.
Time frame: 24 months
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Maternite les Bazennes
Dunkirk, France
CHRU de Lille, Hopital Jeanne de Flandre
Lille, France
Universitaeklinikum Erlangen
Erlangen, Germany
Universitats-Frauenklinik Tubingen
Tübingen, Germany
VU Medical Center
Amsterdam, Netherlands
Ullevaal University
Oslo, Norway
Universitats-Frauenklinik
Bern, Switzerland
...and 4 more locations
Pain score
Time frame: Discharge or 24-hour post clamp removal, whichever is earlier
Days to normal activities (household, work and sexual intercourse)
Time frame: Post procedure
Euro-QOL expressed as change from baseline for each of the 6 domains and Visual Analogue Scale (VAS)
Time frame: 1, 3, 6 and 12 months
Nights in hospital
Time frame: Total and post procedure