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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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Allgemeines Krankenhaus, Abteilung für Gynäkologie und Geburtshilfe
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.
Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.
Tumors or cancer of the UTERINE CERVIX.
Pathological processes of the UTERINE CERVIX.
Loss or destruction of the epithelial lining of the UTERINE CERVIX.
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