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Endometrial Ablation With Non-hysteroscopic Methods

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01173965
First Posted: August 3, 2010
Last Update Posted: July 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aristotle University Of Thessaloniki
  Purpose
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.

Condition Intervention Phase
Dysfunctional Uterine Bleeding Device: MEA Device: Novasure Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®)

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Amenorrhoea rates one year after intervention

Enrollment: 66
Study Start Date: January 2008
Study Completion Date: February 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endometrial ablation with microwaves
Endometrial ablation with the use of MEA(microwaves endometrial ablation device)
Device: MEA
Microwave endometrial ablation device
Other Name: Microwaves (MEA®)
Active Comparator: Endometrial ablation with bipolar diathermy
Endometrial ablation with Novasure(bipolar impedence control system)
Device: Novasure
Bipolar impedence control system
Other Name: Bipolar Impedance Control System (Novasure®)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173965


Locations
Greece
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
Thessaloniki, Greece, 56403
Sponsors and Collaborators
Aristotle University Of Thessaloniki
  More Information

Responsible Party: George Pados, 1st Dept Of ObGyn, "Papageorgiou" General Hospital, Medical School, Aristotle University of Thessaloniki
ClinicalTrials.gov Identifier: NCT01173965     History of Changes
Other Study ID Numbers: 3873
First Submitted: August 2, 2010
First Posted: August 3, 2010
Last Update Posted: July 12, 2012
Last Verified: September 2009

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Metrorrhagia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female