Nasospore Stent For Use in Enodscopic Sinus Surgery

This study has been withdrawn prior to enrollment.
(Principal Investigator left the institution requested study terminated.)
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00671541
First received: May 1, 2008
Last updated: February 16, 2012
Last verified: February 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Nasospore Stent For The Use in Endoscopic Sinus Surgery

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: March 2006
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Lahey Clinic, Inc
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
ClinicalTrials.gov Identifier: NCT00671541     History of Changes
Other Study ID Numbers: LCID 2006-026
Study First Received: May 1, 2008
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bacitracin
Gentamicins
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014