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

Tracking Information
First Received Date ^ICMJE	August 2, 2010
Last Updated Date	July 11, 2012
Start Date ^ICMJE	January 2008
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 2, 2010)	Amenorrhoea rates one year after intervention
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01173965 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Endometrial Ablation With Non-hysteroscopic Methods
Official Title ^ICMJE	Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Dysfunctional Uterine Bleeding
Intervention ^ICMJE	Device: MEA Microwave endometrial ablation device Other Name: Microwaves (MEA®) Device: Novasure Bipolar impedence control system Other Name: Bipolar Impedance Control System (Novasure®)
Study Arm (s)	Active Comparator: Endometrial ablation with microwaves Endometrial ablation with the use of MEA(microwaves endometrial ablation device) Intervention: Device: MEA Active Comparator: Endometrial ablation with bipolar diathermy Endometrial ablation with Novasure(bipolar impedence control system) Intervention: Device: Novasure
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	66
Completion Date	February 2011
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	30 Years to 49 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Greece

Administrative Information
NCT Number ^ICMJE	NCT01173965
Other Study ID Numbers ^ICMJE	3873
Has Data Monitoring Committee	No
Responsible Party	George Pados, 1st Dept Of ObGyn, "Papageorgiou" General Hospital, Medical School, Aristotle University of Thessaloniki
Study Sponsor ^ICMJE	Aristotle University Of Thessaloniki
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Aristotle University Of Thessaloniki
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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