|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00671541 |
|
Date of registration:
|
01/05/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Nasospore Stent For Use in Enodscopic Sinus Surgery
|
|
Scientific title:
|
Nasospore Stent For The Use in Endoscopic Sinus Surgery |
|
Date of first enrolment:
|
March 2006 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
http://clinicaltrials.gov/show/NCT00671541 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Peter J. Catalano, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Lahey Clinic |
| | |
|
Key inclusion & exclusion 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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Sinusitis
|
|
Intervention(s)
|
|
Drug: Merogel Nasal Stent and Nasopore Stent
|
|
Drug: Nasopore Stent and either Gentamycin or Bacitracin
|
|
Primary Outcome(s)
|
|
This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution
[Time Frame: prospective]
|
|
Secondary ID(s)
|
|
LCID 2006-026
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|