Nasospore Stent For Use in Enodscopic Sinus Surgery

NCT00671541 | Withdrawn Phase 4

• 1 other identifier: LCID 2006-026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (1)

• This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution

  prospective

Study Arms (2)

Merogel stent vs. Nasopore Stent

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

bacitracin vs. gentamicin treated stent

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: Merogel Nasal Stent and Nasopore Stent; Drug: Nasopore Stent and either Gentamycin or Bacitracin

Interventions

Merogel Nasal Stent and Nasopore Stent DRUG

Merogel Nasal Stent and Nasopore Stent

Also known as: Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stent

Merogel stent vs. Nasopore Stent; bacitracin vs. gentamicin treated stent

Nasopore Stent and either Gentamycin or Bacitracin DRUG

Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)

Also known as: Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stent

bacitracin vs. gentamicin treated stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evaluation by Otolaryngologist \& determined to need endoscopic sinus surgery
• Only subjects with Bilateral disease

You may not qualify if:

• Pediatric subjects(under the age of 18)

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Clinic, Inc

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Interventions

Bacitracin

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter J. Catalano, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: March 1, 2006
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 17, 2012

Record last verified: 2012-02

Locations

US (1)