Cervix Uteri Dilation Clinical Trial
Official title:
Effectiveness and Safety Evaluation of Aqueduct 100-device
Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device, focusing on diagnostic or operative hysteroscopies.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02851953 -
Effectiveness and Safety Evaluation of Aqueduct -100 Device
|
N/A | |
| Completed |
NCT02941211 -
Effectiveness and Safety Evaluation of Aqueduct -100 Device
|
N/A |