Effectiveness and Safety Evaluation of Aqueduct 100-device

Study Overview
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Brief Summary
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Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device, focusing on diagnostic or operative hysteroscopies.

Detailed Description
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There are predominantly two major dilatation techniques that are employed in dilating the cervix. The first technique uses expansible dry solid material, such as laminaria (seaweed) is inserted into the cervix in its dried stiff form. In the cervix it comes into contact with body fluids that cause the laminaria to swell and enlarge the cervical cavity. The second more widespread procedure, involves the use of series of solid, rod like instruments of graduated diameter used in serial fashion by the physician (Hegar dilators). The physician first inserts a rod like dilator and replaces it with the dilator of next higher diameter. This procedure continues until adequate dilatation occurs. The Problem is that each of the above-mentioned methods has its shortcomings: the use of the laminaria method (rarely done) requires preliminary patient visit, for insertion of the laminaria rod and is extremely slow and typically involves often as much as 10-12 hours for a significant amount of dilatation to occur. The use of rod-like instruments (Hegar) requires general or regional anesthesia, when local anesthetics are used, the patient nevertheless frequently experiences a great amount of discomfort from the procedure. The mechanical dilatation of the cervix demands a large amount of longitudinal force that may damage or even puncture the cervix and the uterus. Aqueduct 100 is a catheter for use in dilating various body cavities and especially the human cervix. The device will enable continuous, fast and safe dilatation of the cervix to a pre-determined diameter as a pre-procedure to intrauterine surgeries.

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 dilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects, females, 18 years of age or older. Subjects undergoing diagnostic or operative hysteroscopies Subjects willing to sign informed consent form. Exclusion Criteria: Subjects younger than 18 years of age Subjects unwilling to sign the informed consent form Pregnancy

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 dilation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients in which, through 1 minute dilation with Aqueduct-100, a cervix dilation of 5mm, required for diagnostic/ operative hysteroscopy, is reached. | Efficacy evaluation of Aqueduct-100 | Through study completion, an average of 11 months | 
| Occurrence of Adverse Events | In vivo safety evaluation of using Aqueduct-100 | Through study completion, an average of 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of physicians'overall satisfaction with the device, through a questionnaire |  | Through study completion, an average of 11 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