Nasospore Stent For Use in Enodscopic Sinus Surgery

Phase 4

Withdrawn

• Conditions: Chronic Sinusitis
• Interventions: Drug: Merogel Nasal Stent and Nasopore Stent; Drug: Nasopore Stent and either Gentamycin or Bacitracin

• Registration Number: NCT00671541
• Lead Sponsor: Lahey Clinic

Brief 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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-05
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-16
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Merogel stent vs. Nasopore Stent	Merogel Nasal Stent and Nasopore Stent	This study has two arms consiting of 50 subjects each (100 total) Arm 1 will recieve the standard stent (merogel)in their right sinus and a nasopore stent in their left sinus.
bacitracin vs. gentamicin treated stent	Merogel Nasal Stent and Nasopore Stent	The second arm will consist of 50 new subjects. These 50 subjects will have a nasopore stent placed in the left sinus. The first 25 subjects will have nasopore stent placed postoperatively with a bacitracin soaked nasopore in right sinus the second 25 will have a gentamycin soaked nasopore stent in right sinus.
bacitracin vs. gentamicin treated stent	Nasopore Stent and either Gentamycin or Bacitracin	The second arm will consist of 50 new subjects. These 50 subjects will have a nasopore stent placed in the left sinus. The first 25 subjects will have nasopore stent placed postoperatively with a bacitracin soaked nasopore in right sinus the second 25 will have a gentamycin soaked nasopore stent in right sinus.

Primary Outcome Measures

Name	Time	Method
This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution	prospective

Trial Locations

Locations (1)

Lahey Clinic, Inc; 🇺🇸 Burlington, Massachusetts, United States