Nasospore Stent For Use in Enodscopic Sinus Surgery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Sinusitis	Drug: Merogel Nasal Stent and Nasopore Stent Drug: Nasopore Stent and either Gentamycin or Bacitracin	Phase IV

MedlinePlus related topics:

Sinusitis

ChemIDplus related topics:

Bacitracin Bacitracin zinc Gentamicins Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study

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

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:

This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution [ Time Frame: prospective ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.	Drug: Merogel Nasal Stent and Nasopore Stent Merogel Nasal Stent and Nasopore Stent
2: Experimental 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.	Drug: Nasopore Stent and either Gentamycin or Bacitracin Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671541

Contacts


Contact: Peter J Catalano, MD	781-744-8452	Peter.J.Catalano@Lahey.org

Contact: Joanne Bilmazes, RN	781-744-5088	Joanne.Bilmazes@Lahey.org

Locations


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

Sponsors and Collaborators

Lahey Clinic

Investigators


Principal Investigator:	Peter J. Catalano, MD	Lahey Clinic

More Information

Responsible Party:	Lahey Clinic Medical Center ( Peter J. Catalano )
Study ID Numbers:	LCID 2006-026
First Received:	May 1, 2008
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00671541
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Otorhinolaryngologic Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Salicylsalicylic acid

Gentamicins

Sodium Salicylate

Bacitracin

Sinusitis

Additional relevant MeSH terms:

Protein Synthesis Inhibitors

Anti-Bacterial Agents

Anti-Infective Agents

Anti-Infective Agents, Local

Molecular Mechanisms of Pharmacological Action

Paranasal Sinus Diseases

Therapeutic Uses

Enzyme Inhibitors

Pharmacologic Actions

Nose Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Lahey Clinic
Information provided by:	Lahey Clinic
ClinicalTrials.gov Identifier:	NCT00671541