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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
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysfunctional Uterine Bleeding

Eligibility Criteria

30 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
August 2, 2010
Last Updated
July 11, 2012
Sponsor
Aristotle University Of Thessaloniki
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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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