Effectiveness and Safety Evaluation of Aqueduct -100 Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-11-30

Brief Summary

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Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device

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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.

Conditions

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Cervix Uteri Dilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aqueduct 100 dilation

Uterine cervix dilation through Aqueduct-100 device

Group Type EXPERIMENTAL

Aqueduct -100

Intervention Type DEVICE

Interventions

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Aqueduct -100

Intervention Type DEVICE

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 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes