Back to resultsFetus Weight Estimation by Ultrasound Data Collection
Primary Purpose
Fetal Weight
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SAMPL plain wave algorithm
Sponsored by
About this trial
This is an interventional other trial for Fetal Weight
Eligibility Criteria
Inclusion Criteria:
- Women between 24+0 weeks and 41+6 weeks gestation.
- Women with a singleton viable pregnancy.
Exclusion Criteria:
None
Sites / Locations
- Hille Yaffe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
performing US scans for fetal weight assessment.
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03857204
First Posted
February 12, 2019
Last Updated
December 4, 2019
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03857204
Brief Title
Fetus Weight Estimation by Ultrasound Data Collection
Official Title
Fetus Weight Estimation by Ultrasound Data Collection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Weight
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
performing US scans for fetal weight assessment.
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SAMPL plain wave algorithm
Intervention Description
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.
Primary Outcome Measure Information:
Title
US scans for fetal weight assessment
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women between 24+0 weeks and 41+6 weeks gestation.
Women with a singleton viable pregnancy.
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Shrim, MD
Phone
+972-7744602
Email
AlonS@hy.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Osnat Palgi, BSc.
Email
osnatp@hymc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alon Shrim, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hille Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Fetus Weight Estimation by Ultrasound Data Collection
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