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

NCT01569763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2018-04-18

Study results available
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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.

Conditions

  • Menorrhagia

Interventions

DEVICE

Aurora Endometrial Ablation

Endometrial Ablation using the Aurora Endometrial Ablation system

DEVICE

Rollerball Ablation/Resection

Hysteroscopic rollerball resection/ablation

Sponsors & Collaborators

  • Minerva Surgical, Inc.

    lead INDUSTRY

Principal Investigators

  • Eugene Skalnyi, MD · Minerva Surgical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-01-31
Completion
2018-03-02

Countries

  • United States
  • Canada
  • 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 NCT01569763 on ClinicalTrials.gov