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Sponsored by: |
Lahey Clinic |
Information provided by: | Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00671541 |
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 |
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 |
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.
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Drug: Merogel Nasal Stent and Nasopore Stent
Merogel Nasal Stent and Nasopore Stent
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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.
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Drug: Nasopore Stent and either Gentamycin or Bacitracin
Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peter J Catalano, MD | 781-744-8452 | Peter.J.Catalano@Lahey.org |
Contact: Joanne Bilmazes, RN | 781-744-5088 | Joanne.Bilmazes@Lahey.org |
United States, Massachusetts | |||||
Lahey Clinic, Inc | Recruiting | ||||
Burlington, Massachusetts, United States, 01805 |
Lahey Clinic |
Principal Investigator: | Peter J. Catalano, MD | Lahey Clinic |
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 |
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