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Completed

NCT Number: NCT02851953

Effectiveness and Safety Evaluation of Aqueduct -100 Device

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.

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Key information

Conditions

Cervix Uteri Dilation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Irccs Azienda Ospedaliera Universitaria San Martino Ist

Genova, 16132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subjects younger than 18 years of age.
  • Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis.
  • Subject has been treated with any cervix dilating agent within 2 months before the screening.
  • Known contraindications or hypersensitivity to the components of the investigational product.
  • 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.
  • Subjects undergoing abortion <7 and >9 weeks of pregnancy.
  • Subjects unwilling to sign the informed consent form.

Treatment and study plan

Aqueduct-100

Device

Primary outcomes

  1. Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device.

    Time frame: 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 outcomes

  1. Occurrence of Adverse Events: rate, list and severity of AEs and SAEs.

    Time frame: Through study completion, approximately 9 months

    In vivo safety evaluation of using Aqueduct-100.

  2. Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter)

    Time frame: Through study completion, approximately 9 months

    Duration of the dilation procedure.

  3. Measurement of physicians' satisfaction with the device, through the use of a questionnaire.

    Time frame: Through study completion, approximately 9 months

Sponsors and collaborators

Lead sponsor

Aqueduct Medical Ltd

Industry

Collaborators

  • Sintesi Research Srl

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 2, 2016
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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