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Clinical Evaluation of the Ethmoid Sinus Spacer (SPACER)

Primary Purpose

Sinusitis, Chronic Rhinosinusitis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ethmoid Sinus Spacer

About this trial

This is an interventional treatment trial for Sinusitis, Chronic Rhinosinusitis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Georgia Nasal and Sinus Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ethmoid Sinus Spacer placement

Arm Description

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

Outcomes

Primary Outcome Measures

Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant

Secondary Outcome Measures

Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures

Full Information

NCT ID

NCT01054703

First Posted

January 20, 2010

Last Updated

June 29, 2017

Sponsor

Acclarent

1. Study Identification

Unique Protocol Identification Number

NCT01054703

Brief Title

Clinical Evaluation of the Ethmoid Sinus Spacer

Acronym

SPACER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study.

Study Start Date

April 1, 2007 (Actual)

Primary Completion Date

November 1, 2007 (Actual)

Study Completion Date

November 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acclarent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sinusitis, Chronic Rhinosinusitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ethmoid Sinus Spacer placement

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Ethmoid Sinus Spacer

Other Intervention Name(s)

Acclarent Ethmoid Sinus Spacer and Access System

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant

Time Frame

Procedural and 6 weeks post-implant

Secondary Outcome Measure Information:

Title

Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures

Time Frame

1 wk, 2wk, 4wk, 6wk

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 21 years old Both male and female Ethmoid disease on CT scan At least one non-ethmoid sinus requiring treatment Failed medical management and symptomatic Exclusion Criteria: Previous ethmoid surgery Not sufficient room for placement of Spacer Patient requires septoplasty Has received steroid treatment with in 2 weeks Extensive sinonasal osteoneogenesis preventing device placement Sinonasal tumors or obstructive lesions History of facial trauma that distorts sinus anatomy Asthmatic patients with aspirin sensitivity Pregnant or lactating females

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fred Kuhn, MD

Organizational Affiliation

Georgia Nasal and Sinus Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgia Nasal and Sinus Institute

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31404

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Evaluation of the Ethmoid Sinus Spacer

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