Nasospore Stent For Use in Enodscopic Sinus Surgery

Condition(s) targeted: Chronic Sinusitis

Intervention: Merogel Nasal Stent and Nasopore Stent (Drug); Nasopore Stent and either Gentamycin or Bacitracin (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Lahey Clinic

Official(s) and/or principal investigator(s):
Peter J. Catalano, MD, Principal Investigator, Affiliation: Lahey Clinic

The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.

Official title: Nasospore Stent For The Use in Endoscopic Sinus Surgery

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution

Detailed description: This study will compare other sinus stenting products to the Nasopore stent. The stents will be soaked in antibiotic solutions and be observed for how well they perform. Subjects will have a stent placed in each sinus, stents may be the standard antibiotic saturated materials or the new nasopore material or nasopore stent soaked in antibiotics.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Evaluation by Otolaryngologist & determined to need endoscopic sinus surgery

- Only subjects with Bilateral disease

Exclusion Criteria:

- Pediatric subjects(under the age of 18)

Lahey Clinic, Inc, Burlington, Massachusetts 01805, United States

Starting date: March 2006
Last updated: February 16, 2012