ContraceptionNCT01861886
The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
A study testing ESS505 (BAY1454033) in people with Contraception, run by Bayer at 5 sites in 2 countries.
Trial summary
To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy. Read more about this study
- Who is it for?
- Ages 21 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- ESS505 (BAY1454033)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 31 Jan 2013to 30 Sep 2014
- Phase
- Interventional
- 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 21 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female with age range 21 to 44 years
- Subjects who are seeking permanent contraception
- Subjects with body weight within range of 40 - 136 kilograms (90-300 pounds)
- Subjects willing to accept the risk of pregnancy occurring while relying solely on the ESS505 as contraception
- Subjects for whom medical history and physical examination indicates bilateral viable and patent fallopian tubes
- Subjects who are able to comply with the protocol required follow-up visits (e.g., 3 month clinic visit, and the 12-month telephone interview)
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- Subjects who provide written informed consent prior to enrolment
- Subjects who have sufficient mental capability to provide clinically relevant and reliable feedback regarding her experience wearing the device
- Subjects agrees that her anonymised personal data will be made available to Study sponsor, requisite regional and international regulatory bodies
- Subjects for whom there are no contraindications for use as described in the ESS505 Instructions for Use (IFU)
Who cannot join
- Subjects with known proximal tubal occlusion in either fallopian tube
- Subjects who have undergone fallopian tube sterilization procedure
- Subjects diagnosed with unicornuate uterus
- Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assessment
- Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure
- Subjects suspected of being or confirmed pregnant
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- Subjects post-partum or has undergone pregnancy termination ≤6 weeks of scheduled ESS505 placement
- Subjects diagnosed with active upper or lower pelvic infection
- Subjects for whom there are one or more contraindications for use as described in the ESS505 IFU
- Subjects have positive pre-procedure pregnancy test
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Netherlands4 sites
Study site
Hoofddorp, 2134 TM
Study site
Nieuwegein, 3435 CM
Study site
Tiel, 4002 WP
Study site
Zwolle, 8025 AB
About this study
Official title: A Multi-Centre Clinical Study to Evaluate the Safety and Effectiveness of the ESS505® Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception
To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.
Read the detailed description
This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
- Conditions
- Contraception
- Being tested
- ESS505 (BAY1454033)
- Keywords
- Birth control, Permanent Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESS505 (BAY1454033)Device
Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 in the proximal portion of the fallopian tubes using a transvaginal approach. Subsequent transvaginal ultrasound (TVU) or hysterosalpingogram (HSG) was performed approximately ≤ 3 hours and 90 days following insert placement.
| Study group | Role | What they receive |
|---|---|---|
| ESS505 | Experimental | Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 in the proximal portion of the fallopian tubes using a transvaginal approach. Subsequent transvaginal ultrasound (TVU) or hysterosalpingogram (HSG) was performed approximately ≤ 3 hours and 90 days following insert placement. Receives: Device: ESS505 (BAY1454033) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
Measured: 3 months
Secondary outcomes (5)
Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception
Measured: 12 months
Frequency (number) of reported ESS505 placement procedure-related AEs
Date of enrollment, 31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014.
Measured: 3 months
Severity of reported ESS505 placement procedure-related AEs
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Measured: 3 months
Frequency (number) of reported ESS505 (device) wearing-related AEs
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Measured: 3 months
Severity of reported ESS505 wearing-related AEs
31 JAN 2013 to data cut-off for this interim CSR, 23 FEB 2014
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start31 Jan 2013
- Primary completion19 Dec 2013
- Study completion30 Sep 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861886
- Sponsor's protocol ID
- 16972
- Other IDs
- ESS505-003
- Status last verified
- Mar 2017
- First submitted
- 20 Feb 2013
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Clinical Study to Evaluate the Safety and Effectiveness of the ESS505® Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception
- ClinicalTrials.gov ID
- NCT01861886
- Acronym / sponsor ID
- 16972
- Conditions
- Contraception
- Keywords
- Birth control, Permanent Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2013 (actual)
- Primary completion
- 19 Dec 2013 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 24 May 2013 (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.
To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.
Detailed description
This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESS505 | Experimental | Device: ESS505 (BAY1454033)Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 in the proximal portion of the fallopian tubes using a transvaginal approach. Subsequent transvaginal ultrasound (TVU) or hysterosalpingogram (HSG) was performed approximately ≤ 3 hours and 90 days following insert placement. |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female with age range 21 to 44 years
- Subjects who are seeking permanent contraception
- Subjects with body weight within range of 40 - 136 kilograms (90-300 pounds)
- Subjects willing to accept the risk of pregnancy occurring while relying solely on the ESS505 as contraception
- Subjects for whom medical history and physical examination indicates bilateral viable and patent fallopian tubes
Key exclusion criteria (10 listed)
- Subjects with known proximal tubal occlusion in either fallopian tube
- Subjects who have undergone fallopian tube sterilization procedure
- Subjects diagnosed with unicornuate uterus
- Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assessment
- Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure
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 |
|---|---|---|
| ESS505 (BAY1454033)Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 in the proximal portion of the fallopian tubes using a transvaginal approach. Subsequent transvaginal ultrasound (TVU) or hysterosalpingogram (HSG) was performed approximately ≤ 3 hours and 90 days following insert placement. | Device | ESS505 |
Primary outcome
Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception.
Time frame: 3 months
5 secondary outcomes
Occurrence of confirmed pregnancy at 12 months among successful bilaterally implant subjects relying solely on the ESS505 for contraception
Time frame: 12 months
Frequency (number) of reported ESS505 placement procedure-related AEs
Time frame: 3 months
Severity of reported ESS505 placement procedure-related AEs
Time frame: 3 months
Frequency (number) of reported ESS505 (device) wearing-related AEs
Time frame: 3 months
Severity of reported ESS505 wearing-related AEs
Time frame: 3 months
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 21 Mar 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
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESS505 (BAY1454033) in people with Contraception, run by Bayer at 5 sites in 2 countries.
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 10 inclusion and 10 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Spain. 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?
Occurrence of confirmed pregnancy at 3 months among successful bilateral implant subjects relying solely on the ESS505 for contraception. (time frame: 3 months). 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 21 Mar 2017.