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

March 18, 2025 updated by: Quanta Medical

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: GHADRI RAMAZ, Doctor
  • Phone Number: 02 38 22 65 55
  • Email: GHADRI@RAMAZ.com

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Quanta Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Unintended pregnancy rate
Time Frame: 5 years
Unintended pregnancy rate
5 years
Device expulsion rate
Time Frame: 5 years
Device expulsion rate
5 years
Discontinuation rate
Time Frame: 5 years
Discontinuation rate
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Extra uterine pregnancy rate
Time Frame: 5 years
Extra uterine pregnancy rate
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)
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)
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)
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)
5 years
Removal rate of the UT380® due to excessive bleeding
Time Frame: 5 years
5 years
Removal rate of the UT380® due to pain
Time Frame: 5 years
5 years
Removal rate of the UT380® due to pelvic inflammatory diseases
Time Frame: 5 years
5 years
Removal rate of the UT380® due to other disease relevant in the contexte of the trial
Time Frame: 5 years
5 years
Removal rate of the UT380® due to desired pregnancy
Time Frame: 5 years
5 years
Removal rate of the UT380® due to any other personal reason
Time Frame: 5 years
5 years
Removal rate of the UT380® due to investigator decision
Time Frame: 5 years
5 years
Safety data such as uterin perforation
Time Frame: 5 years
Uterin perforation rate
5 years
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
5 years
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
5 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Quanta Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prodimed S.A.
CCD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2868

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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