Fetal WeightNCT03857204
Fetus Weight Estimation by Ultrasound Data Collection
A study testing SAMPL plain wave algorithm in people with Fetal Weight, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
This research aims to allow deployment \& optimization of SAMPL plain wave algorithm so as to make required advancement towards a light-weight portable US platform or wireless probe - thus elevating clinician's care level and patient treatment by allowing more scan availability and flexibility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Weight
- What is being tested?
- SAMPL plain wave algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to 1 Mar 2022
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 24+0 weeks and 41+6 weeks gestation.
- Women with a singleton viable pregnancy.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Osnat Palgi, BSc. contact
About this study
This research aims to allow deployment \& optimization of SAMPL plain wave algorithm so as to make required advancement towards a light-weight portable US platform or wireless probe - thus elevating clinician's care level and patient treatment by allowing more scan availability and flexibility.
- Conditions
- Fetal Weight
- Being tested
- SAMPL plain wave algorithm
- Medical subject headings
- Fetal Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAMPL plain wave algorithmDevice
SAMPL's plain-wave algorithm allowing portable US or Wireless Probe scanning - thus enabling clinicians with more flexible point-of-care locations when performing US scans for fetal weight assessment.
| Study group | Role | What they receive |
|---|---|---|
| performing US scans for fetal weight assessment. | Experimental | Not described Receives: Device: SAMPL plain wave algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
US scans for fetal weight assessment
- To evaluate SAMPL's plain-wave algorithm allowing portable US or Wireless Probe scanning - thus enabling clinicians with more flexible point-of-care locations when performing US scans for fetal weight assessment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal WeightStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alon Shrim, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857204
- Sponsor's protocol ID
- 0108-18-HYMC
- Status last verified
- Dec 2019
- First submitted
- 12 Feb 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetus Weight Estimation by Ultrasound Data Collection
- ClinicalTrials.gov ID
- NCT03857204
- Acronym / sponsor ID
- 0108-18-HYMC
- Conditions
- Fetal Weight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 27 Feb 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.
This research aims to allow deployment \& optimization of SAMPL plain wave algorithm so as to make required advancement towards a light-weight portable US platform or wireless probe - thus elevating clinician's care level and patient treatment by allowing more scan availability and flexibility.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| performing US scans for fetal weight assessment. | Experimental | Device: SAMPL plain wave algorithm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women between 24+0 weeks and 41+6 weeks gestation.
- Women with a singleton viable pregnancy.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| SAMPL plain wave algorithmSAMPL's plain-wave algorithm allowing portable US or Wireless Probe scanning - thus enabling clinicians with more flexible point-of-care locations when performing US scans for fetal weight assessment. | Device | performing US scans for fetal weight assessment. |
Primary outcome
US scans for fetal weight assessment
Time frame: 1 year
1) To evaluate SAMPL's plain-wave algorithm allowing portable US or Wireless Probe scanning - thus enabling clinicians with more flexible point-of-care locations when performing US scans for fetal weight assessment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
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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.
Osnat Palgi, BSc. contact
Alon Shrim, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAMPL plain wave algorithm in people with Fetal Weight, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Dec 2019. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alon Shrim, MD (+972-7744602, AlonS@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
US scans for fetal weight assessment (time frame: 1 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 5 Dec 2019.