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

Other Preterm Infants Clinical Trial

— INV-CS-001  

Official title:

Clinical Safety and Utility of the Invictus Cranial Support Device (CSD)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02224859
• Other study ID #: INV-CS-001
• Secondary ID: IND/IDE Number -
• Status: Withdrawn
• Phase: N/A
• First received: March 28, 2014
• Last updated: March 23, 2015
• Start date: March 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Invictus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD) when worn by medically stable infants within a neonatal intensive care unit (NICU), to evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as well as initial impressions of safety, by health care providers (HCPs) after placing the current CSD on infants for approximately six (6) hours in a NICU. Specifically, this study will:

• Collect safety information at specified time points (baseline, 15 minutes, 1 hour, 3 hours, and 6 hours) utilizing a widely used dermal assessment tool, health assessments (temperature, pulse, respiration rate), excessive scalp sweating/moisture accumulation, and adverse events, as reflected in the Table 1.0, Time and Events Table.

Additional safety assessments will be performed following the final removal of the CSD from the infants head. Refer to Table 1.0 Time and Events Table and section 6.1.

• Assess the HCP's impression of likely safety and effectiveness (Function Assessments) of the CSD based on experience working with infants in the NICU, Evaluate/Rate the form and fit, and evaluate/rate the ease of application of the product.

• Collect additional feedback (if any) on HCP's impressions of device design and usability based on experience working as a HCP in the NICU

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Weeks to 36 Weeks

Eligibility

Inclusion Criteria:

1. Have a parent(s) or guardian(s) who has provided written informed consent for the patient to participate in the study.

2. Be > 30.0 weeks gestational age at time of enrollment into the study

3. Be in medically stable condition within the NICU

4. Be able to breathe adequately on room air without support

5. Be deemed suitable (i.e., in no acute distress) for participating in the study for approximately six (6) hours, in the investigator's opinion

6. Upon visual inspection have intact skin without breaks and/or lacerations of the scalp or adjacent areas where the CSD will fit

Exclusion Criteria:

1. The use of any additional respiratory support (i.e., intubation, using CPAP, etc.) is required,

2. The patient has any genetic dermatological conditions

3. The patient's head size is not appropriate for the device < 28 centimeters or >34.3 centimeters (< 11 or > 13.5 inches)

4. 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Other Preterm Infants

Intervention

Device:
• HCP will place the Invictus Cranial Support Device (CSD) on the patient
There is no active therapeutic treatment (e.g., medication, stimulation, etc.) associated with this device or study. All supplies for this study will be supplied by the sponsor and returned to them upon completion of the trial. The device used in this study is a soft gel based bonnet referred to as a Cranial Support Device (CSD). In this study, after obtaining written informed consent from the patient's parent(s) or guardian(s) and confirming that the patient meets all inclusion and no exclusion criteria, the study HCP will place the CSD on the selected patient.

Other:
• human intervention
This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD) when worn by medically stable infants within a neonatal intensive care unit (NICU), to evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as well as initial impressions of safety, by health care providers (HCPs) after placing the current CSD on infants for approximately six (6) hours in a NICU

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Invictus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Rating scale data will be collected and analyzed using descriptive statistics to determine overall 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. No hypothesis testing will be conducted. Only descriptive statistics, frequency counts, and proportions will be used to summarize the data. Descriptive statistics, such as number of observations, means, standard deviations, medians, and maximum and minimum values, will be used to summarize the continuous variables. Frequencies and proportions will be used to summarize categorical variables.	Each patient will spend approximately six (6) hours in the study if no adverse experiences	Yes