Obstetric ComplicationNCT06449872
OB-GYN Clinical Validation Study
A study testing Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems in people with Obstetric Complication and GYN Disorders, run by EchoNous Inc. at 1 site in United States.
Trial summary
This is a single-site study evaluating obstetrics and gynecology exam imaging quality by expert users. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Complication, GYN Disorders
- What is being tested?
- Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to 30 Apr 2024
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persons able to:
- Read and sign an English consent form.
- Read and complete an English demographic and general health survey.
- Give consent for participation.
- Able and willing to comply with study requirements.
- Those aged 18 years through 40 years, healthy, particularly in respect to their pregnancy.
- Pregnant individuals who have received a previous ultrasound exam by their physician.
Who cannot join
- Children (minors) under 18 years old.
- Adults over 40 years old.
- Those who cannot or refuse to sign their consent.
- Those who cannot provide informed consent.
- Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by the expectation of medical benefits associated with participation.
- Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by parents, employer or monetary benefit.
- Pregnant individuals who have not received a previous ultrasound exam by their physician.
- Individuals who have had a hysterectomy, oophorectomy, and trachelectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ECHO-007 OB-GYN Clinical Validation Study
This is a single-site study evaluating obstetrics and gynecology exam imaging quality by expert users.
Read the detailed description
Six healthcare professionals with training and experience in Obstetrics and Gynecology ultrasound qualitatively assessed the image quality of the Kosmos Diagnostic Ultrasound System compared to the benchmark Mindray M9 Ultrasound System. Five sonographers were required to complete each scanning cohort of at least three gravid and three non-gravid participants. A sixth sonographer was added to the study to accommodate a scheduling conflict and provided additional image quality data outside of the five completed cohorts.
The following views/structures were assessed for image quality:
Gynecology participants:
- Uterus
- Ovaries
- Endometrial cavity
- Cervix
- Obstetrics participants in their 1st trimester:
- General image quality of the fetus
- Ability to visualize the crown rump length
- Visualization of gestational sac
- Visualization of yolk sac if present
- Obstetrics and participants in their 2nd trimester:
- General image quality of the fetal structures
- Visualization of the amniotic fluid
- Visualization of the placenta
- Cardiac motion in 2D and M-mode with heart rate
Obstetrics and participants in their 3rd trimester:
- General image quality of the fetal structures
- Visualization of the amniotic fluid
- Visualization of the placenta
- Visualization of the maternal cervix
- Cardiac motion in 2D and M-mode with heart rate
- 3 vessel umbilical cord in 2D and Color Doppler The sonographers captured all views/structures on the Mindray M9 Ultrasound System, then switched over to the Kosmos Diagnostic Ultrasound System to capture the same views/structures. Once all views/structures were captured on both ultrasound systems, the healthcare professionals reviewed the images in parallel on each system, then provided a comparison score for Kosmos between 1 and 7.
- Conditions
- Obstetric Complication, GYN Disorders
- Being tested
- Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetrics and Gynecology clinical applications for ultrasound diagnostic systemsDevice
Up to 5 healthcare professionals trained and experienced in Obstetrics and Gynaecology ultrasound qualitatively assessed the diagnostic image quality of the Kosmos Diagnostic Ultrasound System against the benchmark Mindray M9 Ultrasound System.
| Study group | Role | What they receive |
|---|---|---|
| Comparison scanning protocol for OB and GYN clinical applications | Other | Image quality comparative assessment Receives: Device: Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Ultrasound Image Quality Score
Qualitative image assessment of required views/structures generated with Kosmos Diagnostic Ultrasound System versus a cart-based ultrasound system.
Measured: Through study completion, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start24 Oct 2023
- Primary completion29 Nov 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- EchoNous Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Blankenship, MD, Principal investigator, Mercy West Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449872
- Sponsor's protocol ID
- ECHO-007
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECHO-007 OB-GYN Clinical Validation Study
- ClinicalTrials.gov ID
- NCT06449872
- Acronym / sponsor ID
- ECHO-007
- Conditions
- Obstetric Complication, GYN Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- EchoNous Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Jun 2024 (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.
This is a single-site study evaluating obstetrics and gynecology exam imaging quality by expert users.
Detailed description
Six healthcare professionals with training and experience in Obstetrics and Gynecology ultrasound qualitatively assessed the image quality of the Kosmos Diagnostic Ultrasound System compared to the benchmark Mindray M9 Ultrasound System. Five sonographers were required to complete each scanning cohort of at least three gravid and three non-gravid participants. A sixth sonographer was added to the study to accommodate a scheduling conflict and provided additional image quality data outside of the five completed cohorts.
The following views/structures were assessed for image quality:
Gynecology participants:
- Uterus
- Ovaries
- Endometrial cavity
- Cervix
- Obstetrics participants in their 1st trimester:
- General image quality of the fetus
- Ability to visualize the crown rump length
- Visualization of gestational sac
- Visualization of yolk sac if present
- Obstetrics and participants in their 2nd trimester:
- General image quality of the fetal structures
- Visualization of the amniotic fluid
- Visualization of the placenta
- Cardiac motion in 2D and M-mode with heart rate
Obstetrics and participants in their 3rd trimester:
- General image quality of the fetal structures
- Visualization of the amniotic fluid
- Visualization of the placenta
- Visualization of the maternal cervix
- Cardiac motion in 2D and M-mode with heart rate
- 3 vessel umbilical cord in 2D and Color Doppler The sonographers captured all views/structures on the Mindray M9 Ultrasound System, then switched over to the Kosmos Diagnostic Ultrasound System to capture the same views/structures. Once all views/structures were captured on both ultrasound systems, the healthcare professionals reviewed the images in parallel on each system, then provided a comparison score for Kosmos between 1 and 7.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison scanning protocol for OB and GYN clinical applications | Other | Device: Obstetrics and Gynecology clinical applications for ultrasound diagnostic systemsImage quality comparative assessment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Persons able to:
- Those aged 18 years through 40 years, healthy, particularly in respect to their pregnancy.
- Pregnant individuals who have received a previous ultrasound exam by their physician.
Key exclusion criteria (8 listed)
- Children (minors) under 18 years old.
- Adults over 40 years old.
- Those who cannot or refuse to sign their consent.
- Those who cannot provide informed consent.
- Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by the expectation of medical benefits associated with participation.
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 |
|---|---|---|
| Obstetrics and Gynecology clinical applications for ultrasound diagnostic systemsUp to 5 healthcare professionals trained and experienced in Obstetrics and Gynaecology ultrasound qualitatively assessed the diagnostic image quality of the Kosmos Diagnostic Ultrasound System against the benchmark Mindray M9 Ultrasound System. | Device | Comparison scanning protocol for OB and GYN clinical applications |
Primary outcome
Average Ultrasound Image Quality Score
Time frame: Through study completion, up to 1 month
Qualitative image assessment of required views/structures generated with Kosmos Diagnostic Ultrasound System versus a cart-based ultrasound system.
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 10 Jun 2024.
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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.
Robert Blankenship, MD principal investigator
Mercy West Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems in people with Obstetric Complication and GYN Disorders, run by EchoNous Inc. 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 7 inclusion and 8 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 10 Jun 2024. 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?
Average Ultrasound Image Quality Score (time frame: Through study completion, up to 1 month). 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 10 Jun 2024.