Study Stopped
Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study.
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)
1 other identifier
interventional
14
1 country
1
Brief Summary
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 20, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedResults Posted
Study results publicly available
February 24, 2010
CompletedAugust 6, 2024
July 1, 2024
7 months
January 20, 2010
February 8, 2010
July 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures
1 wk, 2wk, 4wk, 6wk
Study Arms (1)
Ethmoid Sinus Spacer placement
EXPERIMENTALEthmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
Interventions
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integra LifeSciences Corporationlead
- Acclarentcollaborator
Study Sites (1)
Georgia Nasal and Sinus Institute
Savannah, Georgia, 31404, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura England, Manager-Clinical Research
- Organization
- Acclarent
Study Officials
- PRINCIPAL INVESTIGATOR
Fred Kuhn, MD
Georgia Nasal and Sinus Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2010
First Posted
January 22, 2010
Study Start
April 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
August 6, 2024
Results First Posted
February 24, 2010
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share