Other Preterm InfantsINV-CS-001NCT02224859
Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.
A study testing HCP will place the Invictus Cranial Support Device (CSD) on the patient and human intervention in people with Other Preterm Infants, run by Invictus Medical, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Other Preterm Infants
- What is being tested?
- HCP will place the Invictus Cranial Support Device (CSD) on the patient and human intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Clinical Safety and Utility of the Invictus Cranial Support Device (CSD)
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.
Read the 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
- Being tested
- HCP will place the Invictus Cranial Support Device (CSD) on the patient, human intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP will place the Invictus Cranial Support Device (CSD) on the patientDevice
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 interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Safety | Other | 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. Receives: Device: HCP will place the Invictus Cranial Support Device (CSD) on the patient; Other: human intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each patient will spend approximately six (6) hours in the study if no adverse experiences
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Why it stopped: Organization has withdrawn their 510k submission and stopped the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invictus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mustafa . Suterwala, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224859
- Sponsor's protocol ID
- INV-CS-001
- Other IDs
- IND/IDE Number - IRB 013-306
- Acronym
- INV-CS-001
- Status last verified
- Mar 2015
- First submitted
- 28 Mar 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Utility of the Invictus Cranial Support Device (CSD)
- ClinicalTrials.gov ID
- NCT02224859
- Acronym / sponsor ID
- INV-CS-001 / INV-CS-001
- Conditions
- Other Preterm Infants
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Organization has withdrawn their 510k submission and stopped the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Invictus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety | Other | Device: HCP will place the Invictus Cranial Support Device (CSD) on the patient, Other: human interventionFollowing 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. |
Who may qualify
- Ages
- 30 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCP will place the Invictus Cranial Support Device (CSD) on the patientThere 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. | Device | Safety |
| human interventionThis 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 | Other | Safety |
Primary outcome
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.
Time frame: Each patient will spend approximately six (6) hours in the study if no adverse experiences
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Related trials for Other Preterm Infants
Recruiting
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa . Suterwala, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCP will place the Invictus Cranial Support Device (CSD) on the patient and human intervention in people with Other Preterm Infants, run by Invictus Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Each patient will spend approximately six (6) hours in the study if no adverse experiences). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.