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Endometrial Ablation With Non-hysteroscopic Methods

NCT ID: NCT01173965

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Dysfunctional Uterine Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endometrial ablation with microwaves

Endometrial ablation with the use of MEA(microwaves endometrial ablation device)

Group Type ACTIVE_COMPARATOR

MEA

Intervention Type DEVICE

Microwave endometrial ablation device

Endometrial ablation with bipolar diathermy

Endometrial ablation with Novasure(bipolar impedence control system)

Group Type ACTIVE_COMPARATOR

Novasure

Intervention Type DEVICE

Bipolar impedence control system

Interventions

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MEA

Microwave endometrial ablation device

Intervention Type DEVICE

Novasure

Bipolar impedence control system

Intervention Type DEVICE

Other Intervention Names

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Microwaves (MEA®) Bipolar Impedance Control System (Novasure®)

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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1st Dept Of ObGyn, "Papageorgiou" General Hospital, Medical School, Aristotle University of Thessaloniki

Locations

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

Thessaloniki, Thessaloniki, Greece

Site Status

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

Thessaloniki, Thessaloniki, Greece

Site Status

Countries

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Greece

Other Identifiers

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3873

Identifier Type: -

Identifier Source: org_study_id