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NCT02017652 · ClinicalTrials.gov registry record
Validation of Fore-Sight Cerebral & Tissue Oximeter Saturation Measurements on Neonates ≤ 5 kg
A clinical trial, sponsored by Sharp HealthCare.
- Completed
- Registry status
- 19
- Enrollment target
NCT02017652: Completed study, sponsored by Sharp HealthCare.
NCT02017652 is a clinical trial that has completed, run by Sharp HealthCare. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02017652 has completed, sponsored by Sharp HealthCare.
- COMPLETED
- Registry status
- 19 participants
- Enrollment target
Study Summary
CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2) measurements. This monitor was recently FDA cleared for use on adult subjects.
Primary Outcome
At or immediately following an umbilical venous blood draw for CO-oximetry, the FS-II NIRS Small sensor will be briefly placed on the abdominal wall for spot check measurements over the 1) left \& 2) right flank, 3) liver and on three intestine locations: just inferior and lateral to the umbilicus in the 4) Right Lower Quadrant (RLQ) and 5) Left Lower Quadrant (LLQ) positions, as well as 6) Mid Lower Quadrant (MLQ). Then a reference FS-I measurement of the 7) flank for 2 minutes will be done.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-12 |
What the finished NCT02017652 record still lists
NCT02017652 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02017652 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02017652 about?
NCT02017652 is a clinical study titled "Validation of Fore-Sight Cerebral & Tissue Oximeter Saturation Measurements on Neonates ≤ 5 kg". CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2) measurements. This monitor was recently FDA cleared for use on adult subjects.
What is the current status of trial NCT02017652?
This trial is currently completed. The enrollment target is 19 participants. The study started on 2013-12. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT02017652?
This trial is sponsored by Sharp HealthCare, which has 32 total clinical trials registered on ClinicalTrials.gov.
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