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First received: April 03, 2024

Clinical Trial: Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Fetal Hypoxia

Study Type: INTERVENTIONAL


Official Title: Trans-Abdominal Fetal Pulse Oximetry - An Early Feasibility Study

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…

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