Surveillance Study of the Contraceptive Intrauterine Device UT380®

Completed

• Conditions: Contraceptive; Complications, Intrauterine

• Registration Number: NCT03642171
• Lead Sponsor: Quanta Medical

Brief 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.

Study Timeline

• Study First Submitted: 2018-07-16
• Study Start: 2018-07-26
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Primary Completion: 2023-07-26
• Status Verified: 2024-03
• Study Completion: 2024-09-23
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Unintended pregnancy rate	5 years	Unintended pregnancy rate
Device expulsion rate	5 years	Device expulsion rate
Discontinuation rate	5 years	Discontinuation rate

Secondary Outcome Measures

Name	Time	Method
Safety data such as uterin perforation	5 years	Uterin perforation rate
Extra uterine pregnancy rate	5 years	Extra uterine pregnancy rate
Removal rate of the UT380® due to pelvic inflammatory diseases	5 years
Assessment of physicians satisfaction regarding the use of the UT380 using 5 points likert scale (1: not at all satisfied 5: very satisfied)	5 years	Physicians satisfaction regarding the use of the UT 380 will be assessed at post implantation visit (2 visits the fisrt year, and one visit per years during the following 4 years) using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Removal rate of the UT380® due to other disease relevant in the contexte of the trial	5 years
Safety data such as any issue occurring immediately after the implantation of the device	5 years	Rate of issue occurring immediately after the implantation of the device
Safety data such as any issue during the device removal (such as pain, breaking device, excessive pulling force…)	5 years	Rate of issue during the device removal
Removal rate of the UT380® due to desired pregnancy	5 years
Removal rate of the UT380® due to any other personal reason	5 years
Assessment of patients satisfaction regarding the use of the UT 380® using 5 points likert scale (1: not at all satisfied 5: very satisfied)	5 years	Patients satisfaction regarding the use of the UT 380® will be assessed at post implantation visit (2 visits the fisrt year, and one visit per years during the following 4 years) using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Removal rate of the UT380® due to excessive bleeding	5 years
Removal rate of the UT380® due to pain	5 years
Removal rate of the UT380® due to investigator decision	5 years
Safety data such as any issue occurring between two visits: Abdominopelvic or uterine pain outside the menstrual cycle, bleeding,	5 years	Rate of issue occurring between two visits

Trial Locations

Locations (1)

Quanta Medical; 🇫🇷 Boulogne-Billancourt, France