Cervix Uteri Dilation
Conditions
Keywords
cervix, cervical dilation, balloon catheter
Brief summary
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.
Interventions
DEVICEAqueduct-100
Sponsors
Sintesi Research Srl
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
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device. | Through study completion, approximately 9 months | The primary outcome of this study is to determine the effectiveness of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter. |
Secondary
| 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 9 months | Duration of the dilation procedure. |
| Occurrence of Adverse Events: rate, list and severity of AEs and SAEs. | Through study completion, approximately 9 months | In vivo safety evaluation of using Aqueduct-100. |
| Measurement of physicians' satisfaction with the device, through the use of a questionnaire. | Through study completion, approximately 9 months | — |
Countries
Italy
Outcome results
None listed