This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons.
1. Group 1 - beginning with the use of the current instructions for use (IFU) will have adjustments made as necessary to the D-UAO procedural steps for uterine artery occlusion confirmed by 2/3-D Power Colour Doppler ultrasound (2/3DPD). 2. Group 2 - verify that optimal D-UAO IFU procedural steps generated in Group 1 as confirmed by 2/3DPD. 3. Group 3 - verify that the optimal D-UAO procedural steps are reproducible in the hands of multiple surgeons in addition to the group 1 investigators, as confirmed by 2/3DPD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device
Allgemeines Krankenhaus, Abteilung für Gynäkologie und Geburtshilfe
Linz, Austria
Frauenklinik, Universitatsklinikum Erlangen
Erlangen, Germany
Vrije Universiteit medisch centrum (VU Medical Center), Dept of Obstetrics and Gynaecology
Amsterdam, Netherlands
Ullevaal University Hospital, Department of Obstetrics & Gynaecology
Oslo, Norway
Optimal procedural steps
Establish and verify optimal procedural steps to obtain and maintain bilateral uterine artery occlusion using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device (D-UAO) for 6 hours, and confirm that these optimal procedural steps are reproducible by multiple surgeons
Time frame: 6 hrs
Fibroid devascularization
Evaluation of the actual and percentage change in the uterine volume, dominant fibroid volume, T2 frequency, contrast enhancement index in the dominant fibroid and the number of patient with complete infarction of all fibroid tissue obtained from a comparison of the baseline and 1 month contrast enhanced MRIs.
Time frame: Baseline and 1 month post procedure
Safety
Incidence of patients with adverse events that result in the following: ureteral stenting, intra-operative or post operative blood transfusion, device related hospitalization \>24hours, interventional treatment for fibroids within 1 month of the D-UAO procedure, DVT or PE, life threatening cardiac or respiratory arrest or other life threatening events
Time frame: Baseline through one month post procedure
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