The purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the Aqueduct 100 device. The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Irccs Azienda Ospedaliera Universitaria San Martino Ist
Genova, Italy
Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device.
The primary outcome of this study is to determine the effectiveness of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter.
Time frame: Through study completion, approximately 9 months
Occurrence of Adverse Events: rate, list and severity of AEs and SAEs.
In vivo safety evaluation of using Aqueduct-100.
Time frame: Through study completion, approximately 9 months
Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter)
Duration of the dilation procedure.
Time frame: Through study completion, approximately 9 months
Measurement of physicians' satisfaction with the device, through the use of a questionnaire.
Time frame: Through study completion, approximately 9 months
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