Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06442358
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2024-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept
Sponsor:
PulseNmore
Organization:
Study Overview
Official Title:
BPP for ME: Self Biophysical Profile Proof of Concept
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: