ContraceptionSUCCES IINCT02510443
Observational Study on Contraception With Essure in France
An observational study of Contraception, run by Bayer at 1 site in France.
Trial summary
Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- ESS305 (Essure, BAY1454032)
- Type of treatment
- Medical device
- How many people
- 2,644 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2008to 25 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients concerned are adult women wishing to undergo tubal sterilization for contraceptive purposes, in accordance with legal provisions, who had given their consent for collection of the data.
Who may be able to join
- Woman ≥ 18 years old,
- Scheduled for Essure procedure
- Patient who has been given appropriate information about the study objectives and procedures and who has given her consent.
Who cannot join
- Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survey on Use and Characteristics of Definitive Contraception With ESsure®
Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.
Read the detailed description
The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice
- Conditions
- Contraception
- Being tested
- ESS305 (Essure, BAY1454032)
- Keywords
- Permanent contraception method, Contraceptive device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESS305 (Essure, BAY1454032)Device
Bilateral insert placement
| Study group | Role | What they receive |
|---|---|---|
| BAY1454032 | All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure Receives: Device: ESS305 (Essure, BAY1454032) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients being satisfied with successful Essure procedure having no complications at 5 years
Patient satisfaction will be assessed on a Likert scale. Complications are migration/expulsion of Essure, infection. Pregnancy will be measured at any time Point.
Measured: At 5 years
Secondary outcomes (8)
Number of patients with moderate or important pain when placement is performed
Visual Analogue Scale (VAS) use to report the pain from 0 (no pain) to 10 (maximal pain). Moderate pain will range from 4 to 6 and important pain will range from 7 to 10 on the VAS.
Measured: At initial visit
Number of unsatisfied patients
Measured: Up to 5 years
Number of satisfied patients at 3, 12 and 24 months
Patients satisfaction assessed by Likert scale.
Measured: At 3 ,12 and 24 months
Number of examinations by patients
Measured: At 3 months
Number of good insert position by implant and patients with success in final result of the procedure
Measured: At 3 months
Causes of unsatisfied patients
Possible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infection
Measured: Up to 5 years
Type of examinations by patients
Ultrasound transvaginale, radiography, or hysterosalpingography (HSG)
Measured: At 3 months
Number of patients with regrets
Measured: At 12 months, 24 months and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study start23 Jun 2008
- Primary completion29 Sep 2016
- Study completion25 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hôpital André Mignot Centre Hospitalier de Versailles
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510443
- Sponsor's protocol ID
- 18097
- Other IDs
- ES0810FR
- Acronym
- SUCCES II
- Status last verified
- Sep 2017
- First submitted
- 15 Jun 2015
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Use and Characteristics of Definitive Contraception With ESsure®
- ClinicalTrials.gov ID
- NCT02510443
- Acronym / sponsor ID
- SUCCES II / 18097
- Conditions
- Contraception
- Keywords
- Permanent contraception method, Contraceptive device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,644 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Hôpital André Mignot Centre Hospitalier de Versailles
- Study start
- 23 Jun 2008 (actual)
- Primary completion
- 29 Sep 2016 (actual)
- Study completion
- 25 Nov 2016 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.
Detailed description
The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY1454032 | – | Device: ESS305 (Essure, BAY1454032)All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients concerned are adult women wishing to undergo tubal sterilization for contraceptive purposes, in accordance with legal provisions, who had given their consent for collection of the data.
Key inclusion criteria (3 listed)
- Woman ≥ 18 years old,
- Scheduled for Essure procedure
- Patient who has been given appropriate information about the study objectives and procedures and who has given her consent.
Key exclusion criteria (1 listed)
- Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESS305 (Essure, BAY1454032)Bilateral insert placement | Device | BAY1454032 |
Primary outcome
Number of patients being satisfied with successful Essure procedure having no complications at 5 years
Time frame: At 5 years
Patient satisfaction will be assessed on a Likert scale. Complications are migration/expulsion of Essure, infection. Pregnancy will be measured at any time Point.
8 secondary outcomes
Number of patients with moderate or important pain when placement is performed
Time frame: At initial visit
Number of unsatisfied patients
Time frame: Up to 5 years
Number of satisfied patients at 3, 12 and 24 months
Time frame: At 3 ,12 and 24 months
Number of examinations by patients
Time frame: At 3 months
Number of good insert position by implant and patients with success in final result of the procedure
Time frame: At 3 months
Causes of unsatisfied patients
Time frame: Up to 5 years
Type of examinations by patients
Time frame: At 3 months
Number of patients with regrets
Time frame: At 12 months, 24 months and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Bayer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients being satisfied with successful Essure procedure having no complications at 5 years (time frame: At 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.