NCT01569763

Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation

Minerva Pivotal Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Minerva Surgical, Inc. · Industry
• Sex: Female
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Menorrhagia is defined as menstrual bleeding in the ovulatory woman exceeding 80 ml per month. Approximately 20-25% of healthy premenopausal women have abnormal uterine bleeding. Menorrhagia can have a negative impact on a woman's lifestyle and self-perception, often leading her to seek definitive treatment. Pharmacologic treatment for menorrhagia is not always successful, and dilatation and curettage typically provides relief for only a few menstrual cycles. Traditionally hysterectomy has been the definitive treatment for menorrhagia. This clinical study evaluates the safety and effectiveness of the Aurora Endometrial Ablation System to provide a therapeutic treatment for menorrhagia due to benign causes by ablating the endometrial lining of the uterus in pre-menopausal women for whom childbearing is complete. Subjects who are randomized to the control group will receive hysteroscopic rollerball/resection ablation. Subjects randomized to the test arm will be treated with the Aurora Endometrial Ablation System.

Conditions

• Menorrhagia

Interventions

Type	Name	Description
DEVICE	Aurora Endometrial Ablation	Endometrial Ablation using the Aurora Endometrial Ablation system
DEVICE	Rollerball Ablation/Resection	Hysteroscopic rollerball resection/ablation

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-01-01
• Completion: 2018-03-02
• First posted: 2012-04-03
• Last updated: 2018-04-18
• Results posted: 2016-05-05

Locations

13 sites across 3 countries: United States, Canada, Mexico