NCT03857204

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

February 12, 2019

Last Update Submit

December 4, 2019

Conditions

Fetal Weight

Outcome Measures

Primary Outcomes (1)

  • US scans for fetal weight assessment

    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.

    1 year

Study Arms (1)

performing US scans for fetal weight assessment.

EXPERIMENTAL
Device: SAMPL plain wave algorithm

Interventions

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.

performing US scans for fetal weight assessment.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between 24+0 weeks and 41+6 weeks gestation.
  • Women with a singleton viable pregnancy.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Fetal Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alon Shrim, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alon Shrim, MD

CONTACT

+972-7744602AlonS@hy.health.gov.il

Osnat Palgi, BSc.

CONTACT

osnatp@hymc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 27, 2019

Study Start

March 1, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

IL(1)