A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System (NCT02023801) | Clinical Trial Compass
CompletedNot Applicable
A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
Mexico24 participantsStarted 2011-08
Plain-language summary
This is a clinical study without a formal hypothesis. The primary objective of the study is to evaluate the use of the Aurora Endometrial Ablation System in achieving a return to normal menstrual blood loss at 12 months post-treatment, in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete or no longer wish to retain fertility.
Who can participate
Age range
25 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
. Refractory menorrhagia with no definable organic cause
. Female subject from age 25 to 50 years
. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
. One of the following criteria:
. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
. Not pregnant and no desire to be pregnant in the future
. Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
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
Reduction in Menstrual Blood Loss to Normal Levels at 12 Months
. Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
Exclusion criteria
. Pregnancy or subject with a desire to conceive
. Endometrial hyperplasia as confirmed by histology
. Presence of active endometritis
. Active pelvic inflammatory disease
. Active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Patient may be considered for study enrollment.
. Presence of bacteremia, sepsis, or other active systemic infection
. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
. Known/suspected gynecological malignancy within the past 5 years