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Search / Trial NCT03472144

Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

Launched by LIFEBRIDGE HEALTH · Mar 13, 2018

Trial Information

Current as of July 05, 2025

Unknown status

Keywords

ClinConnect Summary

STUDY DESIGN 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). Sixty patients will be included in this study. These are patients undergoing balloon sinuplasty for Chronic sinusitis with and without polyps.

As the patients will enter the study- they will be divided into Chronic sinusitis with Polyps (CRSwNP) and Chronic rhinosinusitis without polyps (CRSsNP). Each patient will be assigned in chronological order as they will join the study.

For each group, all even number...

Gender

ALL

Eligibility 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.

About Lifebridge Health

LifeBridge Health is a prominent healthcare organization dedicated to advancing medical research and improving patient care through innovative clinical trials. Based in Baltimore, Maryland, LifeBridge Health integrates a comprehensive network of hospitals, outpatient centers, and specialty clinics to facilitate cutting-edge research across various medical fields. The organization is committed to fostering partnerships with industry leaders and academic institutions, ensuring that its clinical trials adhere to the highest ethical standards and regulatory compliance. By prioritizing patient safety and engagement, LifeBridge Health aims to contribute significantly to the development of new therapies and treatment options that enhance health outcomes in the communities it serves.

Locations

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Alan H. Shikani, MD

Principal Investigator

Sinai Hospital of Baltimore

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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