NCT02023801

A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Minerva Surgical, Inc. · Industry
• Sex: Female
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menorrhagia Due to Benign Causes

Interventions

Type	Name	Description
DEVICE	Aurora Endometrial Ablation System	Ablation of the endometrial lining of the uterus using the Aurora System

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-10-01
• Completion: 2015-05-01
• First posted: 2013-12-30
• Last updated: 2015-11-05
• Results posted: 2015-11-05

Locations

1 site across 1 country: Mexico