Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT01651260
Eligibility Criteria:
Inclusion Criteria:
* Is 18 years of age or older; male or female and requiring oral tracheal intubation.
* Has intact skin on application site.
* Willingly signs or their authorized representative willingly signs the Informed Consent.
* Is qualified to participate in the opinion of the Investigator.
Exclusion Criteria:
* Has an existing neck injury.
* Has protruding upper teeth, without teeth or is unable to wear upper dentures.
* Has facial hair.
* Has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer.
* Has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site.
* Has a known or stated allergy to adhesive bandages, or any of the product types being tested.
* Uses of topical drugs on the application site.
* Uses lotions, creams or oils on the application site.
* Currently is participating in any clinical testing which may affect performance of this device.
* Has been previously intubated with skin irritation or pressure sores surrounding the mouth.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01651260
Study Brief:
Protocol Section:
NCT01651260