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Endometrial Ablation With Non-hysteroscopic Methods

This study has been completed.
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01173965
First received: August 2, 2010
Last updated: July 11, 2012
Last verified: September 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Vaginal Bleeding
U.S. FDA Resources

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

Ages Eligible for Study:   30 Years to 49 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 2, 2010
Last Updated: July 11, 2012
Health Authority: Greece: Medical School, Aristotle University of Thessaloniki

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

ClinicalTrials.gov processed this record on May 19, 2013