Cervical ElastographyNCT03902587
Application of Cervical Elastography in Obstetrics
An observational study of Cervical Elastography, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to develop cervical elastography nomograms using Samsung's novel technology "E-cervix" and determine its ability to predict preterm birth. During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cervical Elastography
- What is being tested?
- Samsung's E-cervix technology
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 25 Jan 2021
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who present for early screening or level II ultrasound, aged 18 to 50 years
Who may be able to join
- Women who present for early screening or level II ultrasound, aged 18 to 50 years, provides written Informed consent and is willing to comply with protocol requirements, and obtained cervical length and measurements using the E-cervix software/hardware
Who cannot join
- >50 years old
- prior cervical surgical procedures (i.e. LEEP procedure, cold knife cone biopsy)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop cervical elastography nomograms using Samsung's novel technology "E-cervix" and determine its ability to predict preterm birth.
During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment.
- Conditions
- Cervical Elastography
- Being tested
- Samsung's E-cervix technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samsung's E-cervix technologyDevice
While patients are having their routine cervical ultrasound assessments which requires a 5 minute time period, we will use the built-in software to obtain additional E-cervix measurements to evaluate the consistency of the cervical os. This will be done within the standard 5 minute period which is typically done to observe for dynamic changes. The measurements will be obtained with the same sonogram machine, using updated software.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Elastography | During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment. Receives: Device: Samsung's E-cervix technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of preterm Births
Measured: 24 Months
Secondary outcomes (1)
E-cervix indices
Pearson or Spearman correlation coefficients will be calculated to determine the association between the cervical length and each of the e-cervix parameters at the baseline assessment at 18-22 weeks.
Measured: 18 Weeks, 19 Weeks, 20 Weeks, 21 Weeks, 22 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start4 Mar 2019
- Primary completion5 Jun 2020
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical ElastographyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Winthrop University Hospital
- Responsible party
- Sponsor
- Investigators
- Martin Chavez, MD, Principal investigator, NYU Winthrop Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902587
- Sponsor's protocol ID
- 18-01598
- Status last verified
- Feb 2021
- First submitted
- 2 Apr 2019
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Cervical Elastography in Obstetrics
- ClinicalTrials.gov ID
- NCT03902587
- Acronym / sponsor ID
- 18-01598
- Conditions
- Cervical Elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Winthrop University Hospital
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 4 Apr 2019 (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 purpose of this study is to develop cervical elastography nomograms using Samsung's novel technology "E-cervix" and determine its ability to predict preterm birth.
During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Elastography | – | Device: Samsung's E-cervix technologyDuring each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who present for early screening or level II ultrasound, aged 18 to 50 years
Key inclusion criteria (1 listed)
- Women who present for early screening or level II ultrasound, aged 18 to 50 years, provides written Informed consent and is willing to comply with protocol requirements, and obtained cervical length and measurements using the E-cervix software/hardware
Key exclusion criteria (2 listed)
- >50 years old
- prior cervical surgical procedures (i.e. LEEP procedure, cold knife cone biopsy)
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 |
|---|---|---|
| Samsung's E-cervix technologyWhile patients are having their routine cervical ultrasound assessments which requires a 5 minute time period, we will use the built-in software to obtain additional E-cervix measurements to evaluate the consistency of the cervical os. This will be done within the standard 5 minute period which is typically done to observe for dynamic changes. The measurements will be obtained with the same sonogram machine, using updated software. | Device | Cervical Elastography |
Primary outcome
Number of preterm Births
Time frame: 24 Months
1 secondary outcome
E-cervix indices
Time frame: 18 Weeks, 19 Weeks, 20 Weeks, 21 Weeks, 22 Weeks
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 3 Feb 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Available upon request.
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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.
Martin Chavez, MD principal investigator
NYU Winthrop Hospital
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 Cervical Elastography, run by NYU Langone Health at 1 site in United States.
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 2 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 3 Feb 2021. 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 United States. 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?
Number of preterm Births (time frame: 24 Months). 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 3 Feb 2021.