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:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT03221192
Eligibility Criteria:
Inclusion Criteria:
* Subject has a clinical diagnosis of bilateral nasal polyps as diagnosed by endoscopy or CT scan.
* Subject is aged 18 or over.
* Subject has severe nasal polyps symptoms defined as a subject-reported nasal obstruction VAS score of \>5.
* Subject had at least one previous surgery in the past ten years for the removal of nasal polyps. Surgery in this case is defined as any procedure involving instruments with resulting incision and removal of polyp tissue from the nasal cavity (polypectomy).
* Subject is currently an eligible candidate for polypectomy defined by an overall subject-reported VAS symptom score of \>7 and an endoscopic bilateral nasal polyp score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
* Subject has symptoms consistent with chronic rhinosinusitis.
* Subject is currently receiving intranasal corticosteroids for the management of their nasal polyps.
* Subject is willing to participate in the study and provide informed consent.
* Subject is an English speaker and is able to read, write and fully understand the English language.
* Subject is willing to and able to attend and participate in a 90-minute interview to discuss their experiences of nasal polyps and obtain their feedback on several symptom/impact questionnaires.
For real-time data capture:
* Subject owns/or has access to either a smartphone \[iPhone Operating System (iOS) or android\] or tablet which has video, audio/microphone and photographic capabilities and access to either the Apple app store or Google play store to download the app.
* Subject is willing and able to take part in the real-time data application task and respond to a series of questions/tasks fielded to them via the application over the course of 10 days and is willing to respond to some brief questions following the real-time data capture task about their experience of using the app and completing the tasks, either during their interview or in a 5-10 minute telephone call following completion of the task.
* Subject would feel comfortable recording short videos of themselves and providing audio commentary in response to questions/tasks.
Exclusion Criteria:
* Subject has a diagnosis of cystic fibrosis.
* Subject has a diagnosis of eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes).
* Subject has a diagnosis of antrochoanal polyps.
* Subject has a diagnosis of nasal septal deviation occluding one nostril.
* Subject has had acute sinusitis or upper respiratory tract infection in the last two week.
* Subject has ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis).
* Subject has had an asthma exacerbation requiring admission to hospital in the last four weeks.
* Subject is currently or has previously taken part in a clinical trial for nasal polyps.
* Subject is unwilling or unable to comply with the requirements of the study or has a physical or mental condition or learning difficulties that, in the opinion of the physician, may affect the subject's ability to participate in the study, the responses he/she might provide or their ability to provide consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03221192
Study Brief:
Protocol Section:
NCT03221192