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Nasospore Stent For Use in Enodscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00671541
Recruitment Status : Withdrawn (Principal Investigator left the institution requested study terminated.)
First Posted : May 5, 2008
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Drug: Merogel Nasal Stent and Nasopore Stent Drug: Nasopore Stent and either Gentamycin or Bacitracin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Nasospore Stent For The Use in Endoscopic Sinus Surgery
Study Start Date : March 2006
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Merogel stent vs. 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.
 Drug: Merogel Nasal Stent and Nasopore Stent
Merogel Nasal Stent and Nasopore Stent
Other Names:
  • Merogel Stent
  • Nasopore Stent
  • Bacatracin soaked stent
  • Gentamicin soaked stent
Experimental: bacitracin vs. gentamicin treated 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.
 Drug: Merogel Nasal Stent and Nasopore Stent
Merogel Nasal Stent and Nasopore Stent
Other Names:
  • Merogel Stent
  • Nasopore Stent
  • Bacatracin soaked stent
  • Gentamicin soaked 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)
Other Names:
  • Merogel Stent
  • Nasopore Stent
  • Bacatracin soaked stent
  • Gentamicin soaked stent


Outcome Measures
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Primary Outcome Measures :
  1. This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution [ Time Frame: prospective ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671541


Locations
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United States, Massachusetts
Lahey Clinic, Inc
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
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Principal Investigator: Peter J. Catalano, MD Lahey Clinic
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00671541    
Other Study ID Numbers: LCID 2006-026
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Sinusitis
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Gentamicins
 Bacitracin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local