Nasospore Stent For Use in Enodscopic Sinus Surgery

Lahey Health

Status and phase: Withdrawn; Phase 4

Conditions: Chronic Sinusitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00671541

LCID 2006-026

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Merogel stent vs. Nasopore Stent

Active Comparator group

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.

Treatment:

Drug: Merogel Nasal Stent and Nasopore Stent

bacitracin vs. gentamicin treated stent

Experimental group

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.

Treatment:

Drug: Merogel Nasal Stent and Nasopore Stent

Drug: Nasopore Stent and either Gentamycin or Bacitracin