Contraceptive UsagePhase 4NCT01327105
Essure Transvaginal Ultrasound (TVU) Study
A Phase 4 study testing TVU in people with Contraceptive Usage, run by Bayer at 21 sites in 4 countries.
Trial summary
The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first permanent birth control method that can be performed in the comfort of a physician's office without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. 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
- Contraceptive Usage
- What is being tested?
- TVU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 17 May 2011to 4 Jul 2023
- Phase
- Phase 4
- 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
- Women who are 21 to 44 years of age
- Women who are between 90-300 pounds (40-136 kilograms)
- Women who are scheduled to undergo an Essure micro-insert placement procedure for permanent birth control
- Women who are willing to accept the risk of pregnancy occurring while relying on the Essure device for prevention of pregnancy
- Women who are believed to have two viable fallopian tubes
- Women who are able and willing to provide written informed consent
Show all 10Show fewer
- Women who have the mental capacity to understand the Informed Consent, comply with the protocol requirements, and provide reliable feedback regarding device wearing
- Women who can be available for all study visits
- Women who are willing to allow data to be shared with the sponsor and with regulatory bodies
- Women who are not contraindicated for the Essure procedure according to the Essure Instructions for Use (IFU)
Who cannot join
- Women who have known proximal tubal occlusion in either fallopian tube
- Women who have had a fallopian tube sterilization procedure
- Women who have a unicornuate uterus
- Women who have known endometrial or myometrial pathology that is likely to prevent access to the fallopian tube ostia
- Women who are scheduled to undergo any other intrauterine procedures at the time of Essure placement
- Women who are pregnant or suspected of being pregnant
Show all 10Show fewer
- Women who have had a delivery or termination of pregnancy within the last six weeks
- Women who have an active or recent upper or lower pelvic infection
- Women who are contraindicated for Essure micro-insert placement according to the Essure Instructions for Use (IFU)
- Women who have a known intolerance to transvaginal imaging
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States13 sites
Study site
Arvada, Colorado, 80005
Study site
Asheville, North Carolina, 28801
Study site
Chandler, Arizona, 85224
Study site
Columbus, Ohio, 43231
Study site
Fort Wayne, Indiana, 46825
Study site
Glendale, Arizona, 85306
Study site
Houston, Texas, 77074
Study site
Phoenix, Arizona, 85032
Study site
Rochester, Minnesota, 55905
Study site
Saginaw, Michigan, 48604
Study site
The Bronx, New York, 10467
Study site
Tucson, Arizona, 85712
Study site
Winston-Salem, North Carolina, 27103
Netherlands6 sites
Study site
Amsterdam, 1061 AE
Study site
Hoofddorp, 2134 TM
Study site
Nieuwegein, 3435 CM
Study site
Tiel, 4002 WP
Study site
Veldhoven, 5504 DB
Study site
Zwolle, 8025 AB
About this study
Official title: Use of Transvaginal Ultrasound to Confirm Essure® Micro-insert Placement in Women: Demonstration of Effectiveness
The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first permanent birth control method that can be performed in the comfort of a physician's office without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is called a hysterosalpingogram and evaluates the location of the inserts and whether the fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to evaluate the location of the inserts.
The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective method of confirming micro-insert location.
Read the detailed description
This study has previously been posted by Conceptus, Inc. (USA).
After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
- Conditions
- Contraceptive Usage
- Being tested
- TVU
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVUDevice
Use of transvaginal ultrasound to determine location of micro-insert
| Study group | Role | What they receive |
|---|---|---|
| TVU | Experimental | Not described Receives: Device: TVU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Rate of pregnancy at 1 and 10 years among subjects relying on Essure micro-inserts for birth control on the basis of the TVU/HSG algorithm
Measured: Annually beginning at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study start17 May 2011
- Primary completion16 Jul 2014
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 547 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
- NCT01327105
- Sponsor's protocol ID
- 16974
- Other IDs
- ESS-TVU
- Status last verified
- Aug 2023
- First submitted
- 30 Mar 2011
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Vleugels M, Cheng RF, Goldstein J, Bangerter K, Connor V. Algorithm of Transvaginal Ultrasound and/or Hysterosalpingogram for Confirmation Testing at 3 Months after Essure Placement. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1128-1135. doi: 10.1016/j.jmig.2017.06.021. Epub 2017 Jun 29.
PubMed 28669895
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transvaginal Ultrasound to Confirm Essure® Micro-insert Placement in Women: Demonstration of Effectiveness
- ClinicalTrials.gov ID
- NCT01327105
- Acronym / sponsor ID
- 16974
- Conditions
- Contraceptive Usage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 May 2011 (actual)
- Primary completion
- 16 Jul 2014 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 1 Apr 2011 (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.
The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first permanent birth control method that can be performed in the comfort of a physician's office without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is called a hysterosalpingogram and evaluates the location of the inserts and whether the fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to evaluate the location of the inserts.
The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective method of confirming micro-insert location.
Detailed description
This study has previously been posted by Conceptus, Inc. (USA).
After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TVU | Experimental | Device: TVU |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women who are 21 to 44 years of age
- Women who are between 90-300 pounds (40-136 kilograms)
- Women who are scheduled to undergo an Essure micro-insert placement procedure for permanent birth control
- Women who are willing to accept the risk of pregnancy occurring while relying on the Essure device for prevention of pregnancy
- Women who are believed to have two viable fallopian tubes
Key exclusion criteria (10 listed)
- Women who have known proximal tubal occlusion in either fallopian tube
- Women who have had a fallopian tube sterilization procedure
- Women who have a unicornuate uterus
- Women who have known endometrial or myometrial pathology that is likely to prevent access to the fallopian tube ostia
- Women who are scheduled to undergo any other intrauterine procedures at the time of Essure placement
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 |
|---|---|---|
| TVUUse of transvaginal ultrasound to determine location of micro-insert | Device | TVU |
Primary outcome
Effectiveness
Time frame: Annually beginning at one year
Rate of pregnancy at 1 and 10 years among subjects relying on Essure micro-inserts for birth control on the basis of the TVU/HSG algorithm
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 3 Aug 2023.
- Derived from this study: PubMed 28669895Vleugels M, Cheng RF, Goldstein J, Bangerter K, Connor V. Algorithm of Transvaginal Ultrasound and/or Hysterosalpingogram for Confirmation Testing at 3 Months after Essure Placement. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1128-1135. doi: 10.1016/j.jmig.2017.06.021. Epub 2017 Jun 29.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TVU in people with Contraceptive Usage, run by Bayer at 21 sites in 4 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Netherlands, Canada, 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Effectiveness (time frame: Annually beginning at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01327105, which also lists 1 linked publication.
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 3 Aug 2023.