Clinical Evaluation of the Ethmoid Sinus Spacer (SPACER)

Integra LifeSciences

Status: Terminated

Conditions: Sinusitis, Chronic Rhinosinusitis

Treatments: Device: Ethmoid Sinus Spacer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01054703

CPR02082

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Ethmoid Sinus Spacer placement

Experimental group

Description:

Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40

Treatment:

Device: Ethmoid Sinus Spacer