Surveillance Study of the Contraceptive Intrauterine Device UT380® (CCDDIUUT)

Quanta Medical

Status: Completed

Conditions: Contraceptive; Complications, Intrauterine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03642171

2868

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®