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Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

NCT03472144 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-03-21

No results posted yet for this study

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).

Conditions

  • Chronic Sinusitis, Ethmoidal
  • Chronic Sinusitis - Ethmoidal Anterior
  • Chronic Sinusitis
  • Chronic Sinusitis - Ethmoidal, Posterior
  • Chronic Sinusitis, Sphenoidal
  • Chronic Sinusitis - Frontoethmoidal
  • Nasal Polyps
  • Nasal Polyp - Posterior

Interventions

DRUG

gel loaded with steroids (momentasone)

One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local corticosteroids (momentasone) after balloon sinuplasty for chronic sinusitis patients.

DRUG

gel loaded with antibiotic (Levofloxacin)

One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients.

DRUG

gel loaded with both steroids and antibiotic

One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local both steroids (momentasone)and antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients.

Sponsors & Collaborators

  • LifeBridge Health

    lead OTHER

Principal Investigators

  • Alan H. Shikani, MD · Sinai Hospital of Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2019-07-07
Completion
2019-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03472144 on ClinicalTrials.gov