Cervix Uteri Dilation
Conditions
Keywords
cervix, cervical dilation, balloon catheter
Brief summary
Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device
Detailed description
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.
Interventions
DEVICEAqueduct -100
Sponsors
Aqueduct Medical Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with dilation of cervix to the diameter needed to perform the intrauterine procedure using Aqueduct-100 device. | Through study completion, approximately 6 months | The primary outcome of this study is to determine the efficacy of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events | Through study completion, approximately 6 months | Safety evaluation of using Aqueduct-100 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter) | Through study completion, approximately 6 months | Duration of the dilation procedure. |
| Measurement of physicians' overall satisfaction with the device through the use of a questionnaire | Through study completion, approximately 6 months | — |
Countries
Spain
Outcome results
None listed