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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02756351
Other study ID # CCNP-01
Secondary ID
Status Completed
Phase N/A
First received April 26, 2016
Last updated July 19, 2016
Start date April 2016
Est. completion date July 2016

Study information

Verified date July 2016
Source CytaCoat AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencySweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date July 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF).

2. Subject is between 18 and 65 years of age.

3. Subjects that have intact, wound free and scar free skin at the Nasal Prong target site.

4. Subject that have intact, irritation-free nasal mucus membrane.

Exclusion Criteria:

1. Pregnant or nursing women.

2. Subjects who are active smokers or using snuff.

3. Subjects currently suffering from a common cold, sinusitis, allergies or sleep apnea.

4. Subjects suffering from and/or subjects that have experienced nosebleed within 1 month prior to entering the study.

5. Subjects using and/or subjects that have used oral or topical antibiotics within 2 weeks prior to entering the study.

6. Subjects using and/or subjects that have used oral or topical anti-inflammatory drugs within 1 week prior to entering the study.

7. Subjects participating in any other clinical study.

8. Subjects diagnosed with any type of skin infection (bacterial, viral or fungal) or inflammatory skin disease including psoriasis, eczema or severe acne

9. Subjects diagnosed with any type disease affecting mucus membranes.

10. Subjects suffering from any other condition or symptoms preventing the subject from entering the study, according to the investigatorĀ“s judgment.

11. Subjects who have a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the Nasal Prong target site

12. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Intervention

Device:
CytaCoat Nasal Prong

Inspiration Healthcare Inspire nCPAP Nasal Prong


Locations

Country Name City State
Sweden Neonatal, Karolinska University Hospital Stockholm Stockholm County

Sponsors (1)

Lead Sponsor Collaborator
CytaCoat AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
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. 18 hours No
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. 18 hours Yes
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