Effectiveness and Safety Evaluation of Aqueduct -100 Device

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness and Safety Evaluation of Aqueduct -100 Device

Conditions
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Cervix Uteri Dilation

Intervention / Treatment
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* Device: Aqueduct-100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects, females, 18 years of age or older. Subjects undergoing any process that requires dilation (intrauterine procedures). Subjects understanding the nature of the study and willing to sign informed consent form. Exclusion Criteria: Subjects younger than 18 years of age. Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis. Subject has been treated with any cervix dilating agent within 2 months before the screening. Known contraindications or hypersensitivity to the components of the investigational product. The patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures. Subjects undergoing abortion <7 and >9 weeks of pregnancy. Subjects unwilling to sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aqueduct 100 dilation<br>Uterine cervix dilation through Aqueduct-100 device | Device: Aqueduct-100<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, approximately 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Events: rate, list and severity of AEs and SAEs. | In vivo safety evaluation of using Aqueduct-100. | 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. | Through study completion, approximately 9 months | 
| Measurement of physicians' satisfaction with the device, through the use of a questionnaire. |  | Through study completion, approximately 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervix, cervical dilation, balloon catheter