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

2014-08-27 03:13:02 | BioPortfolio

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.

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Uterine Fibroids

Intervention

GYNECARE GYNOCCLUDE™

Location

Allgemeines Krankenhaus, Abteilung für Gynäkologie und Geburtshilfe
Linz
Austria
A-4020

Status

Recruiting

Source

Ethicon, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:02-0400

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Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.

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Pathological processes of the UTERINE CERVIX.

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