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Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding

NCT01979861 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2016-07-12

No results posted yet for this study

Summary

The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)

Conditions

  • Menorrhagia

Interventions

DEVICE

AEGEA Vapor System(TM)

vapor endometrial ablation

Sponsors & Collaborators

  • Aegea Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Levie, MD · Montefiore Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-06-30
Completion
2018-06-30

Countries

  • United States
  • Canada
  • Mexico
  • Netherlands

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 NCT01979861 on ClinicalTrials.gov