Accuracy of Endometrial Volume Measured by VOCAL Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps

Accuracy of Endometrial Volume Measured by Virtual Organ Computer-aided AnaLysis (VOCAL)Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02300805

Acronym

VOCAL

Enrollment

117

Registered

2014-11-25

Start date

2014-11-30

Completion date

2015-12-31

Last updated

2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenopausal; Metrorrhagia

Keywords

Endometrial volume , VOCAL , Endometrial , Metrorrhagia

Brief summary

Endometrial volume will be assessed by 3DUS and VOCAL and compared to the results of office hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women complaining of abnormal uterine bleeding. The safety of both procedures will be compared .

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Age more than 20 years * Patients with irregular vaginal bleeding

Exclusion criteria

* Age less than 20 years * Postmenopausal women * presence of uterine fibroids * Causes of vaginal bleeding due to systemic pathology , anticoagulant use , patients on hormonal contraception or using Intra Uterine Contraceptive Device ( IUCD ) .

Design outcomes

Primary

Measure	Time frame	Description
To measure the Safety and Tolerability and Efficacy of 3DUS versus office Hysteroscopy for diagnosis of endometrial polyps in premenopausal women	one year	A prospective Observational Study

Secondary

Measure	Time frame
To measure the best cut off value for endometrial volume (CC ) using Three Dimensional Sonography ( 3DUS and (VOCAL ) to diagnose endometrial polyps in women with premenopausal bleeding	One year

Countries

Egypt

Outcome results