Effectiveness and Safety Evaluation of Aqueduct -100 Device
Effectiveness and Safety Evaluation of Aqueduct -100 Device
Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device
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.
Inclusion Criteria:

 -  Subjects, females, 18 years of age or older.

 -  Subjects undergoing any process that requires dilation (intrauterine procedures)

 -  Subjects willing to sign informed consent form.

 Exclusion Criteria:

 -  Subjects younger than 18 years of age

 -  Subject with sex transmitted diseases, or with infectious diseases (HIV, HCV).

 -  Subjects unwilling to sign the informed consent form.