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A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis

NCT00840970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-10-01

Study results available
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Summary

The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.

Conditions

  • Chronic Sinusitis

Interventions

DEVICE

non-coated Intranasal Splint

placement of non-coated intranasal splint following FESS

DEVICE

Sinexus Intranasal Splint

placement of Sinexus Intranasal Splint placed following FESS

Sponsors & Collaborators

  • Intersect ENT

    lead INDUSTRY

Principal Investigators

  • Brent Lanier, MD · Central California Ear, Nose, Throat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-03-31
Completion
2009-04-30

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 NCT00840970 on ClinicalTrials.gov