NCT03642171

Surveillance Study of the Contraceptive Intrauterine Device UT380®

A Post Market Surveillance Study of the Performance and Safety of UT 380® Contraceptive Intra Uterine Device in Nulliparous, Uniparous and Multiparous Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Quanta Medical · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Contraceptive; Complications, Intrauterine

Timeline

• Start date: 2018-07-26
• Primary completion: 2023-07-26
• Completion: 2024-09-23
• First posted: 2018-08-22
• Last updated: 2025-03-21

Locations

1 site across 1 country: France