NCT03534362

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

Terminated NA Results posted Last updated 21 April 2020

What this trial tests

NA trial testing Nasopore in Stent in 1 participant. Terminated before completion.

Timeline

13 April 2018

Primary endpoint
23 September 2019

23 September 2019

Quick facts

Lead sponsor	St. Louis University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1
Start date	13 April 2018
Primary completion	23 September 2019
Estimated completion	23 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Nasopore
• Propel

Conditions studied

• Stent — all drugs for Stent →
• Sinusitis, Frontal — all drugs for Sinusitis, Frontal →

Sponsor

St. Louis University

Who can join

Adults 18 to 90, any sex, with Stent or Sinusitis, Frontal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.