Endometrial Ablation With Non-hysteroscopic Methods

July 11, 2012 updated by: Aristotle University Of Thessaloniki

Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®)

Endometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. This study aims to prove that amenorrhoea rates using Novasure are higher than those observed in microwave endometrial ablation, one year following intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 56403
        • First Dept. Of ObGyn, Medical School Aristotle University of Thessaloniki, Papageorgiou Hospital
      • Thessaloniki, Greece, 56403
        • First Dept. of ObGyn, Medical School, Aristotle University of Thessaloniki, Papageorgiou Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women presenting with dysfunctional uterine bleeding having completed their family planning(no wish for further childbearing)

Exclusion Criteria:

  • Endometrial pathology
  • FSH > 20 day 2 -day 3 of the cycle
  • Clotting Disorders
  • Thyroid Dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Endometrial ablation with microwaves
Endometrial ablation with the use of MEA(microwaves endometrial ablation device)
Device: MEA
Microwave endometrial ablation device
Other Names:
  • Microwaves (MEA®)
ACTIVE_COMPARATOR: Endometrial ablation with bipolar diathermy
Endometrial ablation with Novasure(bipolar impedence control system)
Device: Novasure
Bipolar impedence control system
Other Names:
  • Bipolar Impedance Control System (Novasure®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Amenorrhoea rates one year after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (ESTIMATE)

August 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3873

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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