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Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation
NCT01569763 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to evaluate the safety and effectiveness of the Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months post-treatment.
Conditions Studied
Interventions
- DEVICE Aurora Endometrial Ablation
- DEVICE Rollerball Ablation/Resection
Study Locations (13)
Arizona
- New Horizons Women's Care — Chandler
- Women's Health Research — Phoenix
Quebec
- La Cite Medicale — Québec
- Hôpital LaSalle — Ville Lassalle
Indiana
- Basinski, LLC — Newburgh
Kansas
- Cypress Medical Research Center, LLC — Wichita
Minnesota
- Minnesota Gynecology and Surgery — Edina
Missouri
- Mercy Clinic Minimally Invasive Gynecology — St Louis
Tennessee
- Tennessee Women's Care PC — Nashville
Texas
- Baylor Research Institute — Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2012-03 |
| Est. Completion | 2018-03-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01569763
The ClinicalTrials.gov registry entry for NCT01569763 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Minerva Surgical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Menorrhagia appearing as the primary indexed condition, and to 2 interventions — of which Aurora Endometrial Ablation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01569763 reports 13 study locations spanning 11 distinct geographic areas — top geographies include Arizona, Quebec, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01569763 about?
NCT01569763 is a clinical study titled "Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation". The primary objective of this study is to evaluate the safety and effectiveness of the Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months post-treatment.
What is the current status of trial NCT01569763?
This trial is currently completed. It is a NA study. The enrollment target is 153 participants. The study started on 2012-03. Estimated completion is 2018-03-02.
What conditions does trial NCT01569763 study?
This clinical trial studies the following conditions: Menorrhagia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01569763?
The interventions under investigation include: Aurora Endometrial Ablation (DEVICE), Rollerball Ablation/Resection (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01569763?
This trial is sponsored by Minerva Surgical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01569763 being conducted?
This trial has 13 study locations across Arizona, Indiana, Kansas, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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