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A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

NCT01253577 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2015-06-22

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).

Conditions

  • Chronic Sinusitis

Interventions

DEVICE

Sinus Stent with drug coating

Sinus stent coated with 370 ug of the corticosteroid mometasone furoate

DEVICE

Non Coated Sinus Stent

Sinus stent (visually identical) without drug coating

Sponsors & Collaborators

  • Intersect ENT

    lead INDUSTRY

Principal Investigators

  • Bradley Marple, MD · University of Texas

  • Neil Bhattacharyya, MD · Brighan & Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-10-31
Completion
2010-10-31

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 NCT01253577 on ClinicalTrials.gov