Effectiveness and Safety Evaluation of Aqueduct -100 Device

Not Applicable

Completed

• Conditions: Cervix Uteri Dilation
• Interventions: Device: Aqueduct-100

• Registration Number: NCT02851953
• Lead Sponsor: Aqueduct Medical Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aqueduct 100 dilation	Aqueduct-100	Uterine cervix dilation through Aqueduct-100 device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Measurement of physicians' satisfaction with the device, through the use of a questionnaire.	Through study completion, approximately 9 months
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.
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.

Trial Locations

Locations (1)

Irccs Azienda Ospedaliera Universitaria San Martino Ist; 🇮🇹 Genova, Italy