WithdrawnNot Applicable

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

Stopped: Organization has withdrawn their 510k submission and stopped the study

United States0Started 2014-03

Plain-language summary

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.

Who can participate

Age range30 Weeks – 36 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device.

Timeframe: Each patient will spend approximately six (6) hours in the study if no adverse experiences

Trial details

NCT IDNCT02224859

SponsorInvictus Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-01

View on ClinicalTrials.gov More Other Preterm Infants trials