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Nasospore Stent For Use in Enodscopic Sinus Surgery

Primary Purpose

Chronic Sinusitis

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Merogel Nasal Stent and Nasopore Stent
Nasopore Stent and either Gentamycin or Bacitracin
Sponsored by
Lahey Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Lahey Clinic, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Merogel stent vs. Nasopore Stent

bacitracin vs. gentamicin treated stent

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 1, 2008
Last Updated
February 16, 2012
Sponsor
Lahey Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00671541
Brief Title
Nasospore Stent For Use in Enodscopic Sinus Surgery
Official Title
Nasospore Stent For The Use in Endoscopic Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator left the institution requested study terminated.
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lahey Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Merogel stent vs. Nasopore Stent
Arm Type
Active Comparator
Arm Description
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.
Arm Title
bacitracin vs. gentamicin treated stent
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Merogel Nasal Stent and Nasopore Stent
Other Intervention Name(s)
Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stent
Intervention Description
Merogel Nasal Stent and Nasopore Stent
Intervention Type
Drug
Intervention Name(s)
Nasopore Stent and either Gentamycin or Bacitracin
Other Intervention Name(s)
Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stent
Intervention Description
Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)
Primary Outcome Measure Information:
Title
This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution
Time Frame
prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Catalano, MD
Organizational Affiliation
Lahey Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Clinic, Inc
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States

12. IPD Sharing Statement

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Nasospore Stent For Use in Enodscopic Sinus Surgery

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