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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT07027267
Eligibility Criteria:
Inclusion Criteria:
* ≥18 to ≤ 70 years of age at time of consent
* Subject scheduled to undergo bilateral endoscopic sinus surgery
* Able to speak, read and understand English
* Willing and able to provide informed consent and comply with the study protocol
Exclusion Criteria:
* History of removal of one or both middle turbinates
* Presence of significant concha bullosa, which requires surgical excision
* Presence of non-viable tissue at the implantation site
* Active infection at the implantation site
* Chronic nasal decongestant use (i.e. Afrin, etc)
* Recreational intra-nasal drug use within 12 months of enrollment
* Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
* Hypersensitivity to any investigational device materials including known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07027267
Study Brief:
Protocol Section:
NCT07027267