ContraceptionESS-NSPASNCT01740687
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
An observational study of Contraception and Menorrhagia, run by Bayer at 17 sites in United States.
Trial summary
The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Contraception, Menorrhagia
- What is being tested?
- ESS305 (Essure, BAY1454032) and NovaSure
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 211 participants
- Where
- 17 sitesUnited States
- Study dates
- 13 Nov 2012to 14 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Clinics and hospitals
Who may be able to join
- All inclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation (EA) System Instructions for Use and Controller Operator's Manual will apply.
- Women experiencing menorrhagia due to benign causes
- Women who are relying on the Essure micro-inserts for permanent contraception following a successful Essure Confirmation Test (as applicable to the Post Approval Study)
- Women willing to accept the risk of pregnancy while relying on the Essure micro-inserts for prevention of pregnancy following a NovaSure ablation procedure for menorrhagia
Who cannot join
- All exclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation System Instructions for Use and Controller Operator's Manual will apply.
- Women who previously underwent a fallopian tube sterilization procedure (other than Essure placement)
- Women who present with any other medical complaints, conditions or symptoms unrelated to the Essure System and/or subsequent NovaSure EA including, but not limited to:
- Gynecological co-morbidities (e.g., pelvic infection, cervicitis, undiagnosed vaginal bleeding, endometrial cancer, myomas, and polyps)
- Reproductive tract anatomical variants and/or pathology which could make the subject unsuitable for the Essure and/or NovaSure transcervical procedures
- Women currently wearing an intrauterine device and unwilling to have it removed before NovaSure
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Aurora, Colorado, 80045
Study site
Decatur, Illinois, 62526
Study site
Easton, Maryland, 21601
Study site
Englewood, Ohio, 45322
Study site
Fort Wayne, Indiana, 46825
Study site
Grand Blanc, Michigan, 48439
Study site
Las Vegas, Nevada, 89102
Study site
Maplewood, Minnesota, 55109
Study site
Mason, Ohio, 45040
Study site
Nashville, Tennessee, 37232
Study site
Neptune City, New Jersey, 07753
Study site
Newburgh, Indiana, 47630
Study site
Norfolk, Virginia, 23507
Study site
Ocala, Florida, 34471
Study site
Pottstown, Pennsylvania, 19464
Study site
Spokane, Washington, 99204
Study site
Winston-Salem, North Carolina, 27103
About this study
The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.
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, Menorrhagia
- Being tested
- ESS305 (Essure, BAY1454032), NovaSure
- Keywords
- Endometrial Ablation, Permanent Sterilization, Essure, NovaSure, Prevention of Pregnancy
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESS305 (Essure, BAY1454032)Device
Essure Permanent Birth Control
NovaSureProcedure or surgery
Nova Sure Endometrial Ablation
| Study group | Role | What they receive |
|---|---|---|
| Essure+NovaSure | The group of women relying on Essure micro-inserts for permanent birth control when NovaSure is performed following a successful Essure Confirmation Test Receives: Device: ESS305 (Essure, BAY1454032); Procedure: NovaSure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)
Measured: 1 year after NovaSure Endometrial Ablation procedure
Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)
Measured: 3 years after NovaSure Endometrial Ablation procedure
Secondary outcomes (1)
Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts
An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. A serious adverse event (SAE) is classified as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another serious or important medical event (IME) as judged by the investigator, or requires intervention to prevent permanent impairment of a body function or damage to a body structure.
Measured: After 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study start13 Nov 2012
- Primary completion17 May 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 211 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
- NCT01740687
- Sponsor's protocol ID
- 16975
- Acronym
- ESS-NSPAS
- Status last verified
- Feb 2023
- First submitted
- 27 Nov 2012
- Last updated
- 6 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
- ClinicalTrials.gov ID
- NCT01740687
- Acronym / sponsor ID
- ESS-NSPAS / 16975
- Conditions
- Contraception, Menorrhagia
- Keywords
- Endometrial Ablation, Permanent Sterilization, Essure, NovaSure, Prevention of Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2012 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Posted 6 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Essure+NovaSure | – | Device: ESS305 (Essure, BAY1454032), Procedure: NovaSureThe group of women relying on Essure micro-inserts for permanent birth control when NovaSure is performed following a successful Essure Confirmation Test |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Clinics and hospitals
Key inclusion criteria (4 listed)
- All inclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation (EA) System Instructions for Use and Controller Operator's Manual will apply.
- Women experiencing menorrhagia due to benign causes
- Women who are relying on the Essure micro-inserts for permanent contraception following a successful Essure Confirmation Test (as applicable to the Post Approval Study)
- Women willing to accept the risk of pregnancy while relying on the Essure micro-inserts for prevention of pregnancy following a NovaSure ablation procedure for menorrhagia
Key exclusion criteria (6 listed)
- All exclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation System Instructions for Use and Controller Operator's Manual will apply.
- Women who previously underwent a fallopian tube sterilization procedure (other than Essure placement)
- Women who present with any other medical complaints, conditions or symptoms unrelated to the Essure System and/or subsequent NovaSure EA including, but not limited to:
- Women currently wearing an intrauterine device and unwilling to have it removed before NovaSure
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)Essure Permanent Birth Control | Device | Essure+NovaSure |
| NovaSureNova Sure Endometrial Ablation | Procedure or surgery | Essure+NovaSure |
Primary outcome
Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)
Time frame: 1 year after NovaSure Endometrial Ablation procedure
Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)
Time frame: 3 years after NovaSure Endometrial Ablation procedure
1 secondary outcome
Number of Adverse Events (AEs) When NovaSure Endometrial Ablation Was Performed in the Presence of Essure Inserts
Time frame: After 3-year follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Contraception
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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Menorrhagia, run by Bayer at 17 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 4 inclusion and 6 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 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Pregnancies at 1-year Time Point (1-year Pregnancy Rate) (time frame: 1 year after NovaSure Endometrial Ablation procedure). The study lists 2 primary outcomes in all. 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 6 Feb 2023.