Postmenopausal BleedingNCT03404154
Vocal in Assessment of Endometrium in Postmenopause
An observational study of Postmenopausal Bleeding, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia \& carcinoma and lead to irregular bleeding Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Bleeding
- What is being tested?
- 3D ultrasound and Dilatation and curretage
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2018to 25 Aug 2018
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.
Who may be able to join
- -Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relation Between Endometrial Volume by 3D Vocal Ultrasound and Histopathology in Women With Postmenopausal Bleeding
The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia \& carcinoma and lead to irregular bleeding
Read the 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 . .
- Conditions
- Postmenopausal Bleeding
- Being tested
- 3D ultrasound, Dilatation and curretage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D ultrasoundDiagnostic test
it describes the diagnostic test which is 3D us to diagnose the cause of postmenopausal bleeding
Dilatation and curretageProcedure or surgery
it describes the surgical maneuver that will be made to diagnose cause of bleeding
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start18 Jan 2018
- Primary completion1 Aug 2018
- Study completion25 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital, om almasreen hospital ,Egypt, National Research Centre, Egypt
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404154
- Sponsor's protocol ID
- vocal
- Status last verified
- Oct 2018
- First submitted
- 12 Jan 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Endometrial Volume by 3D Vocal Ultrasound and Histopathology in Women With Postmenopausal Bleeding
- ClinicalTrials.gov ID
- NCT03404154
- Acronym / sponsor ID
- vocal
- Conditions
- Postmenopausal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital, om almasreen hospital ,Egypt, National Research Centre, Egypt
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 25 Aug 2018 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 . .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.
Key inclusion criteria (1 listed)
- -Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D ultrasoundit describes the diagnostic test which is 3D us to diagnose the cause of postmenopausal bleeding | Diagnostic test | – |
| Dilatation and curretageit describes the surgical maneuver that will be made to diagnose cause of bleeding | Procedure or surgery | – |
Primary outcome
the number of participants who where diagnosed by 3D vocal to have endometrial carcinoma
Time frame: within 4 weeks
it describes how many women will be properly diagnosed with carcinoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Postmenopausal Bleeding
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Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Active, not recruitingObservational study
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Abnormal Uterine Bleeding (AUB), Endometrial Cancer
Not yet recruitingObservational study
Hysteroscopic Findings With Histopathologic Report of Endometrium in Patients With Postmenopausal Bleeding
Postmenopausal Bleeding
RecruitingObservational study
Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding
Endometrial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alalfy principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Bleeding, run by Aljazeera Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of participants who where diagnosed by 3D vocal to have endometrial carcinoma (time frame: within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.