Endometrial Ablation With Non-hysteroscopic Methods | NCT01173965

Studies
Endometrial Ablation With Non-hysteroscopic Methods

NCT01173965

Sponsor

Aristotle University Of Thessaloniki

Status

Completed

Last Update Posted

Jul 12, 2012Estimated

Enrollment

66Actual

Phase

Phase 4

Conditions

Dysfunctional Uterine Bleeding

Interventions

MEA
Novasure

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Aug 2, 2010

First Submission Date that Met QC Criteria

Aug 2, 2010

First Posted Date

Aug 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2012

Last Update Posted Date

Jul 12, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MEA	Device	Microwave endometrial ablation device	Endometrial ablation with microwaves

Measure	Description	Time Frame
Amenorrhoea rates one year after intervention

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Dept. Of ObGyn, Medical School Aristotle University of Thessaloniki, Papageorgiou Hospital		Thessaloniki	Thessaloniki	56403	Greece

Condition Browse Module

MeSH Terms

ID	Term
D008796	Metrorrhagia

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided