NCT01140555

A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DEVICE	GYNECARE GYNOCCLUDE™	GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2010-06-09
• Last updated: 2011-02-17

Locations

4 sites across 4 countries: Austria, Germany, Netherlands, Norway