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NCT01569763 · ClinicalTrials.gov registry record · NA
Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation
A NA study of Menorrhagia, sponsored by Minerva Surgical.
- Completed
- Registry status
- NA
- Development phase
- 153
- Enrollment target
- 13
- Study locations
NCT01569763: Completed NA study of Menorrhagia, sponsored by Minerva Surgical.
NCT01569763 is a NA study of Menorrhagia that has completed, run by Minerva Surgical. The registered enrollment target is 153 participants, below the 213-participant average among 10 other Menorrhagia trials with a reported enrollment target (28% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01569763, a NA study of Menorrhagia, has completed, sponsored by Minerva Surgical.
- COMPLETED
- Registry status
- NA
- Development phase
- 153 participants
- Enrollment target
- 13
- Study locations
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.
Primary Outcome
Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.
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 |
What the finished NCT01569763 record still lists
NCT01569763 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 213-participant average among 10 other Menorrhagia trials with a reported enrollment target (28% lower).
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.
NCT01569763 lists 13 locations in 11 states (Arizona, Quebec, Indiana).
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.
What interventions are being tested in trial NCT01569763?
The interventions under investigation include: Aurora Endometrial Ablation (DEVICE), Rollerball Ablation/Resection (DEVICE).
Who is sponsoring clinical trial NCT01569763?
This trial is sponsored by Minerva Surgical, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Menorrhagia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01569763's enrollment target sits among peer trials
153 7th of 10 higher than 4 of 10 other Menorrhagia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menorrhagia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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