Endometrial Ablation With Non-hysteroscopic Methods

Dysfunctional Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173965
• Other study ID #: 3873
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2010
• Last updated: July 11, 2012
• Start date: January 2008
• Est. completion date: February 2011

Study information

• Verified date: September 2009
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Medical School, Aristotle University of Thessaloniki
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysfunctional Uterine Bleeding
• Metrorrhagia
• Uterine Hemorrhage

Intervention

Device:
• MEA
Microwave endometrial ablation device
• Novasure
Bipolar impedence control system

Locations

Country	Name	City	State
Greece	First Dept. Of ObGyn, Medical School Aristotle University of Thessaloniki, Papageorgiou Hospital	Thessaloniki
Greece	First Dept. of ObGyn, Medical School, Aristotle University of Thessaloniki, Papageorgiou Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amenorrhoea rates one year after intervention