Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis

Withdrawn before enrolling · Early Phase 1

Conditions studied: Chronic Sinusitis, Rhinosinusitis

In brief

The purpose of this study is to learn whether there is a difference in postoperative (after surgery) endoscopic appearance of the sinus cavities (the way that the sinuses look through a camera) between sinuses that receive one of two types of resorbable steroid eluting sinus packing (a sponge-like material which dissolves within several days while releasing a steroid): 1) Propel Implant or 2) Nasopore soaked with triamcinolone at the time of endoscopic sinus surgery (ESS) for chronic rhinosinusitis.

Key facts

Study ID

NCT03729310

Run by

Weill Medical College of Cornell University

People needed

0

Starts

2020-03-01

Expected to finish

2020-05-26

Last updated by the study team

2020-05-28

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients undergoing endoscopic sinus surgery for the treatment of chronic rhinosinusitis refractory to medical management

You may not qualify if…

• Patients ineligible for informed consent
• Patients unwilling or unable to comply with the postoperative visits necessary for data collection
• Patients with a history of intolerance to triamcinolone
• Patients with suspected systemic inflammatory disease, cystic fibrosis, and any contraindication to systemic corticosteroids.
• As standard of care, the PI does not operate on pregnant patients. A pregnant patient would not be a candidate for the study.

Where it is running

• Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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