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

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ClinicalTrials.gov Identifier: NCT02300805
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
dr mohamed laban, Ain Shams University

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 .


Condition or disease
Premenopausal; Metrorrhagia

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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of Endometrial Volume Measured by Virtual Organ Computer-aided AnaLysis (VOCAL)Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps
Study Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015



Primary Outcome Measures :
  1. To measure the Safety and Tolerability" and "Efficacy of 3DUS versus office Hysteroscopy for diagnosis of endometrial polyps in premenopausal women [ Time Frame: one year ]
    A prospective Observational Study


Secondary Outcome Measures :
  1. 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 [ Time Frame: One year ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Premenopausal women complaining of irregular vaginal bleeding
Criteria

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 ) .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300805


Locations
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Egypt
Ain Shams Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

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Responsible Party: dr mohamed laban, professor mohammed laban, Ain Shams University
ClinicalTrials.gov Identifier: NCT02300805     History of Changes
Other Study ID Numbers: lab7681
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by dr mohamed laban, Ain Shams University:
Endometrial volume , VOCAL , Endometrial , Metrorrhagia

Additional relevant MeSH terms:
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Metrorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes