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Clinical Evaluation of the Ethmoid Sinus Spacer (SPACER)

This study has been completed.
Sponsor:
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT01054703
First received: January 20, 2010
Last updated: June 10, 2011
Last verified: June 2011

January 20, 2010
June 10, 2011
April 2007
November 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Completed
14
November 2007
November 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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01054703
CPR02082
No
Laura England, Manager- Clinical Affairs, Acclarent, Inc.
Acclarent
Not Provided
Principal Investigator: Fred Kuhn, MD Georgia Nasal and Sinus Institute
Acclarent
June 2011

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