Nasospore Stent For Use in Enodscopic Sinus Surgery

Chronic Sinusitis Clinical Trial

Official title:

Nasospore Stent For The Use in Endoscopic Sinus Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00671541
• Other study ID #: LCID 2006-026
• Status: Withdrawn
• Phase: Phase 4
• First received: May 1, 2008
• Last updated: February 16, 2012
• Start date: March 2006
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Sinusitis

Intervention

Drug:
• Merogel Nasal Stent and Nasopore Stent
Merogel Nasal Stent and Nasopore Stent
• Nasopore Stent and either Gentamycin or Bacitracin
Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)

Locations

Country	Name	City	State
United States	Lahey Clinic, Inc	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution		prospective	No