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

NCT02023801 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-11-05

Study results available
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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

DEVICE

Aurora Endometrial Ablation System

Ablation of the endometrial lining of the uterus using the Aurora System

Sponsors & Collaborators

  • Minerva Surgical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-10-31
Completion
2015-05-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02023801 on ClinicalTrials.gov