Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Chronic Sinusitis, Ethmoidal, Chronic Sinusitis - Ethmoidal Anterior, Chronic Sinusitis, Chronic Sinusitis - Ethmoidal, Posterior, Chronic Sinusitis, Sphenoidal, Chronic Sinusitis - Frontoethmoidal, Nasal Polyps, Nasal Polyp - Posterior

In brief

To assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected).

Key facts

Study ID

NCT03472144

Run by

LifeBridge Health

People needed

60

Starts

2017-07-07

Expected to finish

2019-12-07

Last updated by the study team

2018-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic sinusitis symptoms with or without polyps
• Trial of at least 2 courses of oral antimicrobial treatment without significant improvement
• CAT scan showing evidence of bilateral symmetric chronic sinusitis with or without polypss
• Endoscopic confirmation of CRS

You may not qualify if…

• Minor (Less than \<18 years of age).
• Pregnant and breastfeeding women.
• Allergy to specific antibiotics
• Patient currently taking oral corticosteroids.
• Patient currently taking oral antibiotics.

Where it is running

• Sinai Hospital of Baltimore — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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