Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

• Status: Unknown status
• Trial end date: 2019-12-07
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LifeBridge Health
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

1. Chronic sinusitis symptoms with or without polyps

2. Trial of at least 2 courses of oral antimicrobial treatment without significant improvement

3. CAT scan showing evidence of bilateral symmetric chronic sinusitis with or without polypss

4. Endoscopic confirmation of CRS

Exclusion Criteria:

1. Minor (Less than <18 years of age).

2. Pregnant and breastfeeding women.

3. Allergy to specific antibiotics

4. Patient currently taking oral corticosteroids.

5. Patient currently taking oral antibiotics.