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Clinical Evaluation of the Ethmoid Sinus Spacer (SPACER)

This study has been terminated.
(Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054703
First Posted: January 22, 2010
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Acclarent
January 20, 2010
January 22, 2010
February 8, 2010
February 24, 2010
August 7, 2017
April 1, 2007
November 1, 2007   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01054703 on ClinicalTrials.gov Archive Site
Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures [ Time Frame: 1 wk, 2wk, 4wk, 6wk ]
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of the Ethmoid Sinus 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
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sinusitis, Chronic Rhinosinusitis
Device: Ethmoid Sinus Spacer
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
Other Name: Acclarent Ethmoid Sinus Spacer and Access System
Experimental: Ethmoid Sinus Spacer placement
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
Intervention: Device: Ethmoid Sinus Spacer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
November 1, 2007
November 1, 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01054703
CPR02082
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Plan to Share IPD: No
Acclarent
Acclarent
Not Provided
Principal Investigator: Fred Kuhn, MD Georgia Nasal and Sinus Institute
Acclarent
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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