Premenopausal; MetrorrhagiaVOCALNCT02300805
Accuracy of Endometrial Volume Measured by VOCAL Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps
An observational study of Premenopausal; Metrorrhagia, run by Ain Shams University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Premenopausal; Metrorrhagia
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2014to Dec 2015
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal women complaining of irregular vaginal bleeding
Who may be able to join
- Age more than 20 years
- Patients with irregular vaginal bleeding
Who cannot join
- 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 ) .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Endometrial Volume Measured by Virtual Organ Computer-aided AnaLysis (VOCAL)Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps
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 .
- Conditions
- Premenopausal; Metrorrhagia
- Keywords
- Endometrial volume , VOCAL , Endometrial , Metrorrhagia
- Medical subject headings
- Metrorrhagia
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the Safety and Tolerability" and "Efficacy of 3DUS versus office Hysteroscopy for diagnosis of endometrial polyps in premenopausal women
A prospective Observational Study
Measured: one year
Secondary outcomes (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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenopausal; MetrorrhagiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohamed laban, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300805
- Sponsor's protocol ID
- lab7681
- Acronym
- VOCAL
- Status last verified
- Jan 2016
- First submitted
- 18 Nov 2014
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Endometrial Volume Measured by Virtual Organ Computer-aided AnaLysis (VOCAL)Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps
- ClinicalTrials.gov ID
- NCT02300805
- Acronym / sponsor ID
- VOCAL / lab7681
- Conditions
- Premenopausal; Metrorrhagia
- Keywords
- Endometrial volume , VOCAL , Endometrial , Metrorrhagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Nov 2014 (estimated)
- 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.
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 .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal women complaining of irregular vaginal bleeding
Key inclusion criteria (2 listed)
- Age more than 20 years
- Patients with irregular vaginal bleeding
Key exclusion criteria (4 listed)
- 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 ) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
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 12 Jan 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Premenopausal; Metrorrhagia, run by Ain Shams University 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 2 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 12 Jan 2016. 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?
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). 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 12 Jan 2016.