Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.

Withdrawn before enrolling · Not applicable

Conditions studied: Other Preterm Infants

In brief

While using the device as a cushion, the passive distribution of pressure over bony skull prominences of infants will protect against formation of pressure ulcers.

Key facts

Study ID

NCT02224859

Run by

Invictus Medical, Inc.

People needed

0

Starts

2014-03-01

Expected to finish

2015-01-01

Last updated by the study team

2015-03-24

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Have a parent(s) or guardian(s) who has provided written informed consent for the patient to participate in the study.
• Be > 30.0 weeks gestational age at time of enrollment into the study
• Be in medically stable condition within the NICU
• Be able to breathe adequately on room air without support
• Be deemed suitable (i.e., in no acute distress) for participating in the study for approximately six (6) hours, in the investigator's opinion
• Upon visual inspection have intact skin without breaks and/or lacerations of the scalp or adjacent areas where the CSD will fit

You may not qualify if…

• The use of any additional respiratory support (i.e., intubation, using CPAP, etc.) is required,
• The patient has any genetic dermatological conditions
• The patient's head size is not appropriate for the device < 28 centimeters or >34.3 centimeters (< 11 or > 13.5 inches)
• Patient has significant medical condition(s) (e.g., encephalocele, IVH, Shunt, etc.) that makes participating in the study not in the patient's best interest

Where it is running

• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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