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

Chronic Sinusitis Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

1. The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA.

2. Nasopore soaked with triamcinolone. This "packing' is a sponge-like material which dissolves while releasing triamcinolone, which is another type of steroid. Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA.

Both of these procedures are currently used regularly by Dr. Pearlman in practice at the conclusion of ESS for treatment of chronic rhinosinusitis. As standard of care, treatment is determined intraoperatively (during surgery), at the discretion of the surgeon. In this study, each subject will have both treatments (one in each cavity). The 'experimental' aspect relates to directly comparing the two procedures.

This research study is being done because there is currently a lack of consensus regarding the optimal nasal packing regimen. There have been no comparison studies and practice patterns vary widely. Our study looks to compare the Propel implant to Nasopore packing soaked in Triamcinolone. ;

Related Conditions & MeSH terms

• Chronic Sinusitis
• Rhinosinusitis
• Sinusitis

• NCT number: NCT03729310
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: March 2020
• Completion date: May 26, 2020