Phase 3 Chronic Rhinosinusitis Trial, Completed

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been diagnosed with chronic sinusitis (long-term inflammation of the sinuses)
• You have had surgery to remove tissue from both sides of your sinuses (called bilateral total ethmoidectomy), and this surgery was done at least 90 days ago
• You have nasal polyps growing back on both sides, rated at a certain level of severity (Grades 1–3), with at least one side rated Grade 2
• You are willing and able to follow the study requirements
• You have ongoing sinus symptoms despite using a steroid nasal spray or rinse at least once a day for at least 2 weeks before joining
• You have tried a stronger form of steroids (such as tablets, injections, or sinus rinses with steroids) in the past 2 years, or you were unable to tolerate them
• You have a history of needing repeated courses of strong steroid treatment for recurring sinusitis
• A camera examination of your sinuses shows polyps returning, scarring, or swollen tissue blocking your sinuses
• You score at least 2 out of 5 on a list of key sinus symptoms (such as nasal blockage, nasal drip, thick discharge, facial pain/pressure, or reduced sense of smell) on a standard questionnaire
• You are able to tolerate local numbing medication and a procedure done in a clinic setting
• Your doctor believes the implant or comparison procedure can be physically placed in your sinuses on both sides
• You have signed a consent form agreeing to take part
• If you are a woman who could become pregnant, you must not currently be pregnant and must agree to use reliable birth control throughout the study

Who may not be able to join:

• You had sinus surgery less than 90 days ago
• You had a Propel implant placed less than 90 days ago
• You have severe scarring or tissue bands (called adhesions) inside your sinuses, rated at Grade 3 or 4
• You have nasal polyps rated at the most severe level (Grade 4)
• You have a known immune system deficiency (such as certain antibody deficiencies or HIV)
• You are currently receiving chemotherapy or immunotherapy for a condition such as cancer or HIV
• You depend on oral steroids (steroid tablets) to manage a condition such as severe asthma or COPD
• You have a known allergy or bad reaction to corticosteroids or the specific steroid used in this study (mometasone furoate)
• You have a history of not responding well to oral steroids
• You have a physical blockage in your nose that would prevent the device from being placed (such as a severely crooked nasal wall, very small passageways, or severe scarring)
• You currently have signs of an active bacterial sinus infection (such as increased thick discharge, fever, or facial pain)
• There is suspicion or evidence of a serious fungal sinus infection
• You have a serious illness that could affect your health or ability to complete 6 months of follow-up visits
• You have taken part in another clinical trial in the last 30 days
• You have insulin-dependent diabetes
• You had a spinal fluid leak or lasting vision problems as a result of a previous sinus surgery
• Your middle turbinate (a structure inside your nose) has been completely removed
• There is a known gap or weakness in the thin bone wall near your eye socket (confirm with trial site)
• You have an active viral illness such as tuberculosis, eye herpes, chickenpox, or measles
• You have been diagnosed with glaucoma or high pressure in your eyes
• You have a specific type of eye angle problem (closed-angle condition) (confirm with trial site)
• You have certain types of cataracts rated at a moderate-to-severe level in either eye

Important: Always verify eligibility with the trial site directly before applying.