Clinical Evaluation of the Ethmoid Sinus Spacer

Not Applicable

Terminated

• Conditions: Sinusitis, Chronic Rhinosinusitis

• Registration Number: NCT01054703
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-01
• Primary Completion: 2007-11-01
• Study Completion: 2007-11-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Results First Submitted: 2010-02-08
• Results First Submitted QC: 2010-02-08
• Results First Posted: 2010-02-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Age > 21 years old
2. Both male and female
3. Ethmoid disease on CT scan
4. At least one non-ethmoid sinus requiring treatment
5. Failed medical management and symptomatic

Exclusion Criteria

1. Previous ethmoid surgery
2. Not sufficient room for placement of Spacer
3. Patient requires septoplasty
4. Has received steroid treatment with in 2 weeks
5. Extensive sinonasal osteoneogenesis preventing device placement
6. Sinonasal tumors or obstructive lesions
7. History of facial trauma that distorts sinus anatomy
8. Asthmatic patients with aspirin sensitivity
9. Pregnant or lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant	Procedural and 6 weeks post-implant

Secondary Outcome Measures

Name	Time	Method
Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures	1 wk, 2wk, 4wk, 6wk

Trial Locations

Locations (1)

Georgia Nasal and Sinus Institute; 🇺🇸 Savannah, Georgia, United States