Nasospore Stent For The Use in Endoscopic Sinus Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Lahey Clinic
- Locations
- 1
- Primary Endpoint
- This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Merogel stent vs. Nasopore Stent
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.
Intervention: Merogel Nasal Stent and Nasopore Stent (Drug)
bacitracin vs. gentamicin treated stent
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: Merogel Nasal Stent and Nasopore Stent (Drug)
bacitracin vs. gentamicin treated stent
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: Nasopore Stent and either Gentamycin or Bacitracin (Drug)
Outcomes
Primary Outcomes
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 Outcomes
No secondary outcomes reported