Clinical Evaluation of the Ethmoid Sinus Spacer (SPACER)

Clinical Evaluation of the Safety and Feasibility of the Ethmoid Sinus Spacer and Access System With Drug (SPACER)

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

Study Overview

• Status: Terminated
• Conditions: Sinusitis, Chronic Rhinosinusitis
• Intervention / Treatment: Device: Ethmoid Sinus Spacer

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Georgia Nasal and Sinus Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ethmoid Sinus Spacer placement; Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40	Device: Ethmoid Sinus Spacer; Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40; Other Names: Acclarent Ethmoid Sinus Spacer and Access System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Acclarent
• Investigators: Principal Investigator: Fred Kuhn, MD, Georgia Nasal and Sinus Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: CPR02082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes