This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Endometrial Ablation With Non-hysteroscopic Methods

This study has been completed.
Information provided by:
Aristotle University Of Thessaloniki Identifier:
First received: August 2, 2010
Last updated: July 11, 2012
Last verified: September 2009
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®)


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01173965

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 Identifier: NCT01173965     History of Changes
Other Study ID Numbers: 3873
Study First Received: August 2, 2010
Last Updated: July 11, 2012

Additional relevant MeSH terms:
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female processed this record on September 21, 2017