A Pilot Study to Determine the Optimal Procedure Steps to Obtain and Maintain Bilateral Uterine Artery Occlusion Using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device in Women With Uterine Fibroids
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
6 hrs
No
David Robinson, M.D.
Study Director
Ethicon, Inc.
Austria: Federal Office for Safety in Health Care
300-09-007
NCT01140555
April 2010
July 2010
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