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Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out

NCT03534362 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-04-21

Study results available
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Summary

Surgery on the frontal sinus is done for patients who have sinus problems that do not respond to medications. It involves making an opening within the right and left frontal sinus of the nose to help it drain. For severe frontal sinus disease, the sinus is widely opened and the left and right sinuses become one large sinus. This is done with sharp instruments and rigid endoscopes placed through the nostrils. While the sinus heals after surgery, a stent or steroids or both may be used to try to help make sure that the opening does not close back up. Two current options for this are Propel stents and steroid-soaked Nasopore. Propel stents are FDA-approved. Nasopore and Kenalog injection are both FDA-approved, but their use together is part of the study and not specifically FDA-approved. A previous study shows that Propel stents are useful to reduce scarring in other frontal sinus procedures. We would like to know whether this is true in larger frontal sinus surgery where one common cavity is made and whether both steroid-containing stents are the same.

Conditions

  • Stent
  • Sinusitis, Frontal

Interventions

DEVICE

Nasopore

Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract

DEVICE

Propel

Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Joe D Brunworth, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-13
Primary Completion
2019-09-23
Completion
2019-09-23
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 NCT03534362 on ClinicalTrials.gov