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

• ClinicalTrials.gov Identifier: NCT03642171
• Recruitment Status: Recruiting
• First Posted: August 22, 2018
• Last Update Posted: September 16, 2020
• Sponsor: Quanta Medical
• Collaborators: Prodimed S.A.; CCD
• Information provided by (Responsible Party): Quanta Medical

Study Description

Brief Summary:

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

Condition or disease
Contraceptive; Complications, Intrauterine

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 Design

• Study Type: Observational
• Estimated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Post Market Surveillance Study of the Performance and Safety of UT 380® Contraceptive Intra Uterine Device in Nulliparous, Uniparous and Multiparous Women
• Actual Study Start Date: July 26, 2018
• Estimated Primary Completion Date: July 16, 2024
• Estimated Study Completion Date: July 16, 2024

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Unintended pregnancy rate [ Time Frame: 5 years ]
   Unintended pregnancy rate
2. Device expulsion rate [ Time Frame: 5 years ]
   Device expulsion rate
3. Discontinuation rate [ Time Frame: 5 years ]
   Discontinuation rate

Secondary Outcome Measures :

1. Extra uterine pregnancy rate [ Time Frame: 5 years ]
   Extra uterine pregnancy rate
2. 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)
3. 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)
4. Removal rate of the UT380® due to excessive bleeding [ Time Frame: 5 years ]
5. Removal rate of the UT380® due to pain [ Time Frame: 5 years ]
6. Removal rate of the UT380® due to pelvic inflammatory diseases [ Time Frame: 5 years ]
7. Removal rate of the UT380® due to other disease relevant in the contexte of the trial [ Time Frame: 5 years ]
8. Removal rate of the UT380® due to desired pregnancy [ Time Frame: 5 years ]
9. Removal rate of the UT380® due to any other personal reason [ Time Frame: 5 years ]
10. Removal rate of the UT380® due to investigator decision [ Time Frame: 5 years ]
11. Safety data such as uterin perforation [ Time Frame: 5 years ]
    Uterin perforation rate
12. 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
13. 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
14. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: UT380® is intended to be used in nulliparous, uniparous and multiparous women
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

The patients will be recruited in France city privates practicing gynaecologist.

Criteria

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®

Contacts and Locations

Contacts

Contact: GHADRI RAMAZ, Doctor; 02 38 22 65 55; GHADRI@RAMAZ.com

Locations

France

Quanta Medical; Recruiting

Rueil-Malmaison, France, 92500

Contact: QUANTA MEDICAL

Sponsors and Collaborators

Quanta Medical

Prodimed S.A.

CCD

More Information

• Responsible Party: Quanta Medical
• ClinicalTrials.gov Identifier: NCT03642171
• Other Study ID Numbers: 2868
• First Posted: August 22, 2018
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Quanta Medical:

Contraception; Intrauterine Device; UT380