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

NCT ID: NCT02224859

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-01-31

Brief 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.

Detailed 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

Conditions

Other Preterm Infants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Safety

Following an initial examination of the scalp and head for baseline evidence of skin integrity (intact, without breaks, lacerations, etc.) and appearance (healthy/normal, no erythema/irritation, etc.) the HCP will place the CSD on the patient and secure the attached Velcro strap to hold the device in place

At specific time points (approximately 15 minutes, 1 hour, 3 hours and 6 hours) the HCP (through human intervention)will remove the CSD for examination and completion of the Skin Assessment Scale based on the appearance of the patient's scalp and adjacent areas of the head. Additionally, the patient's head will be observed for excessive scalp sweating/moisture accumulation.

Group Type: OTHER

HCP will place the Invictus Cranial Support Device (CSD) on the patient

Intervention Type: DEVICE

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.

human intervention

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Invictus Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mustafa . Suterwala, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

IND/IDE Number - IRB 013-306

Identifier Type: OTHER

Identifier Source: secondary_id

INV-CS-001

Identifier Type: -

Identifier Source: org_study_id