ContraceptionPhase 3NCT02064413
Essure (Model ESS310) Placement Rate Study
A Phase 3 study testing ESS310 (BAY1454032) in people with Contraception, run by Bayer at 16 sites in United States.
Trial summary
To evaluate the safety and successful placement rate of Essure Model ESS310 device and any factors that may influence the successful placement rate of this device. 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?
- ESS310 (BAY1454032)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 16 sitesUnited States
- Study dates
- 17 Mar 2014to 26 Nov 2014
- Phase
- Phase 3
- 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
- Females aged range 21 to 44 years
- Subjects seeking permanent contraception
- Subjects with body weight within range of 90-300 pounds (40 - 136 kilograms)
- Subjects for whom medical history indicates bilateral viable and patent fallopian tubes
- Subjects are able and willing to comply with the protocol required follow-up visits
- Subjects have fulfilled local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
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- Subjects provide written informed consent prior to enrolment
- Subjects who have sufficient mental capacity to understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience implant and subsequent wearing of the device
- Subjects who agree that anonymized personal data will be made available to study Sponsor and requisite regional and international regulatory bodies
Who cannot join
- Subjects suspected of being or confirmed pregnant
- Subjects post-partum or undergone pregnancy termination ≤6 weeks of scheduled insert placement
- Subjects who have known proximal tubal occlusion in either fallopian tube
- Subjects who have undergone fallopian tube sterilization procedure
- Subjects who have had total or partial salpingectomies
- Subjects diagnosed with tubal, endometrial, or myometrial pathology which may prevent fallopian tube ostia access
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- Subjects diagnosed with unicornuate uterus
- Subjects diagnosed with active or currently being treated upper or lower pelvic infection
- Subjects with gynecologic malignancy
- Subjects who are currently taking corticosteroids
- Subjects with a known allergy to all contrast media available for use in HSG (Hysterosalpingogram)
- Subjects scheduled to undergo concomitant intrauterine procedures at the time of insert placement (e.g., endometrial ablation, fibroid resection by hysteroscopy, endometrial polypectomy). Intrauterine device removal is not considered a concomitant procedure.
- Subjects with any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy
- Subjects with a close affiliation with the investigational site, e.g. closely related or affiliated with the investigator (such as dependent, employee or student of the investigational site, or sponsor's staff)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Augusta, Georgia, 30909
Study site
Colorado Springs, Colorado, 80923
Study site
Dayton, Ohio, 45409-2793
Study site
Fort Wayne, Indiana, 46825
Study site
Fort Worth, Texas, 76104
Study site
Glendale, Arizona, 85304
Study site
Grand Blanc, Michigan, 48439
Study site
Houston, Texas, 77074
Tennessee Women's Care, PC
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Study site
Newburgh, Indiana, 47630
Study site
Phoenix, Arizona, 85015
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Study site
Saginaw, Michigan, 48604
Wayne State University Physicians Group
Southfield, Michigan, 48034
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multi-Center, United States Clinical Study to Evaluate Placement Success of the ESS310 Essure® System
To evaluate the safety and successful placement rate of Essure Model ESS310 device and any factors that may influence the successful placement rate of this device.
- Conditions
- Contraception
- Being tested
- ESS310 (BAY1454032)
- Keywords
- Birth control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESS310 (BAY1454032)Device
| Study group | Role | What they receive |
|---|---|---|
| ESS310 | Experimental | All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure. Receives: Device: ESS310 (BAY1454032) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement
Measured: Day 1
Secondary outcomes (6)
Successful bilateral placement rate of the ESS310 insert at first attempt in all subjects who undergo hysteroscopy with the intent of having bilateral ESS310 placement
Measured: Day 1
Evaluation of investigator questionnaire regarding ESS310 design and usability
Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt
Measured: Day 1
Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt
Measured: Day 1
Hysteroscopy time to perform the procedure
Measured: Day 1
Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability
Measured: 1 week
Number of participants with Adverse procedure-related events as a measure of safety and tolerability
Measured: Day 1, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study start17 Mar 2014
- Primary completion2 Oct 2014
- Study completion26 Nov 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 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
- NCT02064413
- Sponsor's protocol ID
- 17069
- Status last verified
- Apr 2021
- First submitted
- 14 Feb 2014
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, United States Clinical Study to Evaluate Placement Success of the ESS310 Essure® System
- ClinicalTrials.gov ID
- NCT02064413
- Acronym / sponsor ID
- 17069
- Conditions
- Contraception
- Keywords
- Birth control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 2 Oct 2014 (actual)
- Study completion
- 26 Nov 2014 (actual)
- First posted
- 17 Feb 2014 (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 successful placement rate of Essure Model ESS310 device and any factors that may influence the successful placement rate of this device.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESS310 | Experimental | Device: ESS310 (BAY1454032)All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure. |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Females aged range 21 to 44 years
- Subjects seeking permanent contraception
- Subjects with body weight within range of 90-300 pounds (40 - 136 kilograms)
- Subjects for whom medical history indicates bilateral viable and patent fallopian tubes
- Subjects are able and willing to comply with the protocol required follow-up visits
Key exclusion criteria (14 listed)
- Subjects suspected of being or confirmed pregnant
- Subjects post-partum or undergone pregnancy termination ≤6 weeks of scheduled insert placement
- Subjects who have known proximal tubal occlusion in either fallopian tube
- Subjects who have undergone fallopian tube sterilization procedure
- Subjects who have had total or partial salpingectomies
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 |
|---|---|---|
| ESS310 (BAY1454032) | Device | ESS310 |
Primary outcome
Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement
Time frame: Day 1
6 secondary outcomes
Successful bilateral placement rate of the ESS310 insert at first attempt in all subjects who undergo hysteroscopy with the intent of having bilateral ESS310 placement
Time frame: Day 1
Evaluation of investigator questionnaire regarding ESS310 design and usability
Time frame: Day 1
Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt
Time frame: Day 1
Hysteroscopy time to perform the procedure
Time frame: Day 1
Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability
Time frame: 1 week
Number of participants with Adverse procedure-related events as a measure of safety and tolerability
Time frame: Day 1, 1 week
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 8 Apr 2021.
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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
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ESS310 (BAY1454032) in people with Contraception, run by Bayer at 16 sites in United States.
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 9 inclusion and 14 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement (time frame: Day 1). 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 8 Apr 2021.