Fetus Weight Estimation by Ultrasound Data Collection

Fetal Weight Clinical Trial

Official title:

Fetus Weight Estimation by Ultrasound Data Collection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03857204
• Other study ID #: 0108-18-HYMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: December 2019
• Source: Hillel Yaffe Medical Center
• Contact: Alon Shrim, MD
• Phone: +972-7744602
• Email: AlonS[@]hy.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Women between 24+0 weeks and 41+6 weeks gestation.

2. Women with a singleton viable pregnancy.

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Body Weight
• Fetal Weight

Intervention

Device:
• SAMPL plain wave algorithm
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.

Locations

Country	Name	City	State
Israel	Hille Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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