Vocal in Assessment of Endometrium in Postmenopause | NCT03404154

Studies
Vocal in Assessment of Endometrium in Postmenopause

NCT03404154

Sponsor

Aljazeera Hospital

Status

Completed

Last Update Posted

Oct 2, 2018Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Postmenopausal Bleeding

Interventions

3D ultrasound
Dilatation and curretage

Countries

Egypt

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

Oct 2018

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 18, 2018Actual

Primary Completion Date

Aug 1, 2018Actual

Completion Date

Aug 25, 2018Actual

First Submitted Date

Jan 12, 2018

First Submission Date that Met QC Criteria

Jan 12, 2018

First Posted Date

Jan 19, 2018Actual

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

Oct 1, 2018

Last Update Posted Date

Oct 2, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera HospitalPrincipal Investigator

Lead Sponsor

Aljazeera HospitalOTHER

Collaborators

Name	Class
Kasr El Aini Hospital	OTHER
om almasreen hospital ,Egypt	UNKNOWN
National Research Centre, Egypt	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia & carcinoma and lead to irregular bleeding

Detailed Description

Recent advances in the screening and diagnosis of endometrial pathologies (eg,endometrial hyperplasia , endometrial carcinoma ,endometrial polyps and myomas ) are directed towards non invasive methods as Transvaginal ultrasound with 3 D application using different softwares .

One of the applications of 3D Transvaginal Ultrasonography is Vocal technique ( Virtual Organ Computer aided Analysis ) that can measure volume especially in tissues with irregular borders And this technology is considered to be superior than the conventional 2 D ultrasound . .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D ultrasound	Diagnostic Test	it describes the diagnostic test which is 3D us to diagnose the cause of postmenopausal bleeding
Dilatation and curretage	Procedure	it describes the surgical maneuver that will be made to diagnose cause of bleeding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of participants who where diagnosed by 3D vocal to have endometrial carcinoma	it describes how many women will be properly diagnosed with carcinoma	within 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

Exclusion Criteria:

Women with hormone replacement therapy.
Women showing intra-cavitary fluid collection at ultrasound examination
Women with other gynecological lesions in the pelvis other than the uterus
Previous diagnosis of endometrial pathology.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

postmenopausal women with vaginal bleeding

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy	Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah		Giza			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided