A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation… (NCT01740687) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
United States211 participantsStarted 2012-11-13
Plain-language 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.
Who can participate
Age range
21 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Pregnancies at 1-year Time Point (1-year Pregnancy Rate)
Timeframe: 1 year after NovaSure Endometrial Ablation procedure
2
Number of Pregnancies at 3-year Time Point (3-year Pregnancy Rate)
Timeframe: 3 years after NovaSure Endometrial Ablation procedure