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Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia

NCT02228720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-08-04

Study results available
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Summary

This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.

Conditions

  • Chronic Sinusitis

Interventions

DEVICE

Propel Nova Sinus Implant

Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days

Sponsors & Collaborators

  • Intersect ENT

    lead INDUSTRY

Principal Investigators

  • William J. Brown, MD · South Florida ENT Associates, PA

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-10-31
Completion
2015-01-31
FDA Device
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 NCT02228720 on ClinicalTrials.gov