Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405984
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-03
Brief Title:
Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE
Sponsor:
Raydiant Oximetry Inc
Organization:
Raydiant Oximetry Inc
Study Overview
Official Title:
Trans-Abdominal Fetal Pulse Oximetry - An Early Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-08
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 Lumerah System developed and manufactured by Raydiant Oximetry Inc is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe non-invasive transabdominal near-infrared spectroscopy The Lumerah System is intended as an adjunct to cardiotocography In this study women in labor will also be simultaneously monitored with a re-engineered version of the previously approved transvaginal oximeter sensor connected to a Nellcor N-400 fetal oximetry monitor for the purposes of device development The data obtained from the transabdominal sensor and the transvaginal sensor will be used for research purposes only and will not be used to guide or alter patient management
Detailed Description:
This is a prospective interventional open-label Early Feasibility Study Investigational Device Exemption EFS-IDE The Principal Investigator or research team member will consult a list of eligible patients based on predicted delivery dates and scheduled inductions Women who are planning to undergo labor will be approached regarding this study The study involves measurement of the fetal pulse signal with the investigational device Lumerah during labor Lumerah is an investigational fetal pulse oximeter that measures fetal arterial oxygen saturation using safe non-invasive transabdominal near-infrared spectroscopy The Lumerah device is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation that is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis The subjects will first undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position during labor The results of the sonographic measurements might influence the enrollment suitability of the subject as well as the placement of the Investigational device The Oxiplex TS device a non-ionizing laser system that provides researchers with valuable information regarding maternal optical tissue properties will also be used Once the membranes are ruptured the investigators team will use a Nellcor N-400 System with a sterile single-use transvaginal sensor for data collection only The outcomes of the fetal oxygenation measurements are masked only the Sponsor is aware of the measurements Therefore no clinical decisions will be made based on the information derived from any of the devices used in this study
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44HD094486 | NIH | None | httpsreporternihgovquickSearchR44HD094486 |