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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis Surgery

Drug Information available for: Gentamicins Bacitracin Bacitracin zinc

U.S. FDA Resources

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

No publications provided

Responsible Party:	Lahey Clinic Medical Center ( Peter J. Catalano )
Study ID Numbers:	LCID 2006-026
Study First Received:	May 1, 2008
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00671541 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Otorhinolaryngologic Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Gentamicins
Bacitracin
Sinusitis

Additional relevant MeSH terms:

Anti-Infective Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Paranasal Sinus Diseases
Enzyme Inhibitors
Sinusitis
Bacitracin
Nose Diseases

Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Infective Agents, Local
Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Gentamicins

ClinicalTrials.gov processed this record on September 03, 2009