Effectiveness and Safety Evaluation of Aqueduct -100 Device

Aqueduct Medical

Status: Completed

Conditions: Cervix Uteri Dilation

Treatments: Device: Aqueduct-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT02851953

AQD 01-15

Details and patient eligibility

About

The purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the Aqueduct 100 device.

The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation.

Enrollment: 41 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects, females, 18 years of age or older.
2. Subjects undergoing any process that requires dilation (intrauterine procedures).
3. Subjects understanding the nature of the study and willing to sign informed consent form.

Exclusion criteria

1. Subjects younger than 18 years of age.
2. Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis.
3. Subject has been treated with any cervix dilating agent within 2 months before the screening.
4. Known contraindications or hypersensitivity to the components of the investigational product.
5. The patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures.
6. Subjects undergoing abortion <7 and >9 weeks of pregnancy.
7. Subjects unwilling to sign the informed consent form.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Aqueduct 100 dilation

Experimental group

Description:

Uterine cervix dilation through Aqueduct-100 device

Treatment:

Device: Aqueduct-100