NCT01173965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2008

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 12, 2012

Status Verified

September 1, 2009

Enrollment Period

2.1 years

First QC Date

August 2, 2010

Last Update Submit

July 11, 2012

Conditions

Dysfunctional Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

  • Amenorrhoea rates one year after intervention

Study Arms (2)

Endometrial ablation with microwaves

ACTIVE COMPARATOR

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

Device: MEA

Endometrial ablation with bipolar diathermy

ACTIVE COMPARATOR

Endometrial ablation with Novasure(bipolar impedence control system)

Device: Novasure

Interventions

MEADEVICE

Microwave endometrial ablation device

Also known as: Microwaves (MEA®)
Endometrial ablation with microwaves
NovasureDEVICE

Bipolar impedence control system

Also known as: Bipolar Impedance Control System (Novasure®)
Endometrial ablation with bipolar diathermy

Eligibility Criteria

Age30 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women presenting with dysfunctional uterine bleeding having completed their family planning(no wish for further childbearing)

You may not qualify if:

  • Endometrial pathology
  • FSH \> 20 day 2 -day 3 of the cycle
  • Clotting Disorders
  • Thyroid Dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Thessaloniki, Thessaloniki, 56403, Greece

Location

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

Thessaloniki, Thessaloniki, 56403, Greece

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2010

First Posted

August 3, 2010

Study Start

January 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2011

Last Updated

July 12, 2012

Record last verified: 2009-09

Locations

GR(2)