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

Stopped early · Not applicable

Conditions studied: Stent, Sinusitis, Frontal

In brief

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.

Key facts

Study ID

NCT03534362

Run by

St. Louis University

People needed

1

Starts

2018-04-13

Expected to finish

2019-09-23

Last updated by the study team

2020-04-21

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients able to speak and understand English
• Patients for whom frontal drill out procedure is medically indicated

You may not qualify if…

• Patients who are cognitively impaired and unable to consent
• Patients who are not candidates for Frontal Drill out
• Patients with contraindications to PROPEL Mini sinus implant or Kenalog soaked nasopore: known hypersensitivity to mometasone furoate, Kenalog, lactide, glycolide or caprolactone copolymers
• Non-English speaking patients

Where it is running

• Saint Louis Universtiy — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.