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Endometrial Ablation With Non-hysteroscopic Methods

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT01173965
Collaborator
(none)
66
Enrollment
2
Locations
2
Arms
37
Duration (Months)
33
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: MEA
  • Device: Novasure
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
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®)
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

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®)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Amenorrhoea rates one year after intervention []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 49 Years
    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

    Locations

    Site City State Country Postal Code
    1 First Dept. Of ObGyn, Medical School Aristotle University of Thessaloniki, Papageorgiou Hospital Thessaloniki Greece 56403
    2 First Dept. of ObGyn, Medical School, Aristotle University of Thessaloniki, Papageorgiou Hospital Thessaloniki Greece 56403

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01173965
    Other Study ID Numbers:
    • 3873
    First Posted:
    Aug 3, 2010
    Last Update Posted:
    Jul 12, 2012
    Last Verified:
    Sep 1, 2009
    Additional relevant MeSH terms:
    Uterine Hemorrhage
    Metrorrhagia
    Hemorrhage

    Study Results

    No Results Posted as of Jul 12, 2012