NCT00671541

Nasospore Stent For Use in Enodscopic Sinus Surgery

Nasospore Stent For The Use in Endoscopic Sinus Surgery

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lahey Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DRUG	Merogel Nasal Stent and Nasopore Stent	Merogel Nasal Stent and Nasopore Stent
DRUG	Nasopore Stent and either Gentamycin or Bacitracin	Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)

Timeline

• Start date: 2006-03-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2008-05-05
• Last updated: 2012-02-17

Locations

1 site across 1 country: United States