Quanta Medical
Boulogne-Billancourt, 92100, France
Completed
NCT Number: NCT03642171
Surveillance Study of the Contraceptive Intrauterine Device UT380®
The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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®
Treatment and study plan
Primary outcomes
-
Unintended pregnancy rate
Time frame: 5 years
Unintended pregnancy rate
-
Device expulsion rate
Time frame: 5 years
Device expulsion rate
-
Discontinuation rate
Time frame: 5 years
Discontinuation rate
Secondary outcomes
-
Extra uterine pregnancy rate
Time frame: 5 years
Extra uterine pregnancy rate
-
Assessment of physicians satisfaction regarding the use of the UT380 using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Time frame: 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)
-
Assessment of patients satisfaction regarding the use of the UT 380® using 5 points likert scale (1: not at all satisfied 5: very satisfied)
Time frame: 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
Time frame: 5 years
-
Removal rate of the UT380® due to pain
Time frame: 5 years
-
Removal rate of the UT380® due to pelvic inflammatory diseases
Time frame: 5 years
-
Removal rate of the UT380® due to other disease relevant in the contexte of the trial
Time frame: 5 years
-
Removal rate of the UT380® due to desired pregnancy
Time frame: 5 years
-
Removal rate of the UT380® due to any other personal reason
Time frame: 5 years
-
Removal rate of the UT380® due to investigator decision
Time frame: 5 years
-
Safety data such as uterin perforation
Time frame: 5 years
Uterin perforation rate
-
Safety data such as any issue occurring immediately after the implantation of the device
Time frame: 5 years
Rate of issue occurring immediately after the implantation of the device
-
Safety data such as any issue occurring between two visits: Abdominopelvic or uterine pain outside the menstrual cycle, bleeding,
Time frame: 5 years
Rate of issue occurring between two visits
-
Safety data such as any issue during the device removal (such as pain, breaking device, excessive pulling force…)
Time frame: 5 years
Rate of issue during the device removal
Sponsors and collaborators
Lead sponsor
Quanta Medical
Industry
Collaborators
- CCD
- Prodimed S.A.
Registry information
Official study title
A Post Market Surveillance Study of the Performance and Safety of UT 380® Contraceptive Intra Uterine Device in Nulliparous, Uniparous and Multiparous Women
Acronym: CCDDIUUT
Important dates
- Study start
- 2018
- Primary completion
- 2023
- Study completion
- 2024
- First posted
- Aug 22, 2018
- Registry last updated
- Mar 21, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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