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Surveillance Study of the Contraceptive Intrauterine Device UT380®

Not Recruiting
18 years of age
Female
Phase N/A

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Overview

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

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.

Eligibility

Inclusion Criteria:

  • Woman > 18 years old
  • nulliparous, uniparous and multiparous
  • not currently using a contraceptive method or are willing to switch to a new reversible contraceptive
  • with an indication of implantation of a UT380® IUD
  • agreeing to participate in the study

Exclusion Criteria:

  • Patient with risk of post implantation bleeding or high level of bleeding during menstruation 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 use of UT380®

Study details

Contraceptive; Complications, Intrauterine

NCT03642171

Quanta Medical

21 March 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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