Endometrial Ablation With Non-hysteroscopic Methods
Primary Purpose
Dysfunctional Uterine Bleeding
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
MEA
Novasure
Sponsored by
About this trial
This is an interventional treatment trial for Dysfunctional Uterine Bleeding
Eligibility 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
Sites / Locations
- First Dept. Of ObGyn, Medical School Aristotle University of Thessaloniki, Papageorgiou Hospital
- First Dept. of ObGyn, Medical School, Aristotle University of Thessaloniki, Papageorgiou Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Endometrial ablation with microwaves
Endometrial ablation with bipolar diathermy
Arm Description
Endometrial ablation with the use of MEA(microwaves endometrial ablation device)
Endometrial ablation with Novasure(bipolar impedence control system)
Outcomes
Primary Outcome Measures
Amenorrhoea rates one year after intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT01173965
First Posted
August 2, 2010
Last Updated
July 11, 2012
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT01173965
Brief Title
Endometrial Ablation With Non-hysteroscopic Methods
Official Title
Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional Uterine Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometrial ablation with microwaves
Arm Type
Active Comparator
Arm Description
Endometrial ablation with the use of MEA(microwaves endometrial ablation device)
Arm Title
Endometrial ablation with bipolar diathermy
Arm Type
Active Comparator
Arm Description
Endometrial ablation with Novasure(bipolar impedence control system)
Intervention Type
Device
Intervention Name(s)
MEA
Other Intervention Name(s)
Microwaves (MEA®)
Intervention Description
Microwave endometrial ablation device
Intervention Type
Device
Intervention Name(s)
Novasure
Other Intervention Name(s)
Bipolar Impedance Control System (Novasure®)
Intervention Description
Bipolar impedence control system
Primary Outcome Measure Information:
Title
Amenorrhoea rates one year after intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
First Dept. Of ObGyn, Medical School Aristotle University of Thessaloniki, Papageorgiou Hospital
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
First Dept. of ObGyn, Medical School, Aristotle University of Thessaloniki, Papageorgiou Hospital
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Endometrial Ablation With Non-hysteroscopic Methods
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