Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-02 @ 3:44 PM
Study NCT ID:
NCT03969433
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
Sponsor:
Bloom Technologies
Organization:
Study Overview
Official Title:
Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
Status:
COMPLETED
Status Verified Date:
2022-01
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 purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing.
Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.
The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.
Clinical information related to subjects' pregnancy and foetal health is also collected.
Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.
The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.
Clinical information related to subjects' pregnancy and foetal health is also collected.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: