Surveillance Study of the Contraceptive Intrauterine Device UT380®

Last updated: March 18, 2025
Sponsor: Quanta Medical
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03642171
2868
  • Ages > 18
  • Female

Study Summary

The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Woman > 18 years old

  • nulliparous, uniparous and multiparous

  • not currently using a contraceptive method or are willing to switch to a newreversible contraceptive

  • with an indication of implantation of a UT380® IUD

  • agreeing to participate in the study

Exclusion

Exclusion Criteria:

  • Patient with risk of post implantation bleeding or high level of bleeding duringmenstruation period

  • Patient with a risk of infection

  • Patient that meet any of the absolute contraindication of UT 380®

  • Any other elements that the investigator may think relevant and cannot allow the useof UT380®

Study Design

Total Participants: 200
Study Start date:
July 26, 2018
Estimated Completion Date:
September 23, 2024

Study Description

Prospective data on contraceptive performance of the UT380® from a large number of women are not yet available. Here we describe a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (e.g. age and gender) and information on diagnosis, treatment, response to treatment, follow-up after treatment and patients experience of the treatment. In addition, it also include the health care staff's experience of the use of the UT 380. The result of this study will be used for different purposes e.g. marketing activities such as posters, folders, or targeted journals and/or conferences.

Connect with a study center

  • Quanta Medical

    Boulogne-Billancourt, 92100
    France

    Site Not Available

  • Quanta Medical

    Rueil-Malmaison, 92500
    France

    Site Not Available

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