Endometrial Ablation With Non-hysteroscopic Methods

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.

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Key information

Conditions

Dysfunctional Uterine Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

30 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

First Dept. Of ObGyn, Medical School Aristotle University of Thessaloniki, Papageorgiou Hospital, Thessaloniki, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEA

Device

Microwave endometrial ablation device

Other names: Microwaves (MEA®)

NovaSure

Device

Bipolar impedence control system

Other names: Bipolar Impedance Control System (Novasure®)

Primary outcomes

Amenorrhoea rates one year after intervention

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®)

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Aug 3, 2010
Registry last updated: Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed