A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System

Menorrhagia Due to Benign Causes Clinical Trial

Official title: A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System

Status Completed

Clinical Trial Summary

This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical study is designed as a non-inferiority study to assess the effectiveness of the Aurora Endometrial Ablation System compared to an objective standard. Safety will be evaluated by determining the number and percentage of subjects who experience one or more of serious adverse events.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia
• Menorrhagia Due to Benign Causes

• NCT number: NCT02029911
• Study type: Interventional
• Source: Minerva Surgical, Inc.
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Completion date: June 2015