Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in clinically significant settings such as the neonatal care units.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CytaCoat Nasal Prong | Experimental | The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. |
|
| Reference Nasal Prong | Active Comparator | Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytaCoat Nasal Prong | Device |
| ||
| Inspiration Healthcare Inspire nCPAP Nasal Prong |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device. | 18 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Any Adverse Events Such as Skin Reactions, Allergic Reactions, Abrasions, Shears or Wounds Due to Contact or Pressure of the Device on the Nose of Subjects Occurring During the Study. | 18 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Baldvin Jonsson | Neonatal, Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal, Karolinska University Hospital | Stockholm | Stockholm County | 171 76 | Sweden |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CytaCoat Nasal Prong | The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat Nasal Prong |
| FG001 | Reference Nasal Prong | Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device. Inspiration Healthcare Inspire nCPAP Nasal Prong |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CytaCoat Nasal Prong | The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat Nasal Prong |
| BG001 | Reference Nasal Prong | Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device. Inspiration Healthcare Inspire nCPAP Nasal Prong |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device. | Posted | Mean | Standard Deviation | fold change in log value | 18 hours |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Any Adverse Events Such as Skin Reactions, Allergic Reactions, Abrasions, Shears or Wounds Due to Contact or Pressure of the Device on the Nose of Subjects Occurring During the Study. | Posted | Number | Adverse Events | 18 hours |
|
|
Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CytaCoat Nasal Prong | The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat Nasal Prong | 0 | 24 | 17 | 24 | ||
| EG001 | Reference Nasal Prong | Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device. Inspiration Healthcare Inspire nCPAP Nasal Prong | 0 | 24 | 16 | 24 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mark on columella | Skin and subcutaneous tissue disorders |
| |||
| Pain | Skin and subcutaneous tissue disorders |
| |||
| Mark on tip of the nose | Skin and subcutaneous tissue disorders |
| |||
| Itch | Skin and subcutaneous tissue disorders |
| |||
| Breathing problems | Skin and subcutaneous tissue disorders | Breathing problems due to extra Steri-Strips put over the device. |
| ||
| Humidity | Skin and subcutaneous tissue disorders |
| |||
| Irritation and sore | Skin and subcutaneous tissue disorders |
| |||
| Itch and humidity | Skin and subcutaneous tissue disorders |
| |||
| Mark | Skin and subcutaneous tissue disorders |
| |||
| Psychological | Social circumstances |
| |||
| Sore | Skin and subcutaneous tissue disorders |
| |||
| Stingy | Skin and subcutaneous tissue disorders |
| |||
| Breathing problems and itch | Skin and subcutaneous tissue disorders |
| |||
| Irritation and stingy | Skin and subcutaneous tissue disorders |
| |||
| Sleepwalking, nausea and a feeling of fainting | Social circumstances |
|
As stated in the Clinical Investigation Plan (CIP):
The Principal Investigator may publish results from this investigation; however as some of the information regarding the investigational medical device and development activities may be of a strictly confidential nature, the Sponsor must first be given the opportunity to review any publication manuscript prior to submission to journals, meetings or conferences.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jacob Odeberg | CytaCoat AB | +46 (0) 70 2087571 | jacob.odeberg@scilifelab.se |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077299 | Healthcare-Associated Pneumonia |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|