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Clinical Evaluation of the Ethmoid Sinus Spacer (SPACER)

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.
ClinicalTrials.gov Identifier: NCT01054703
Recruitment Status : Terminated (Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study.)
First Posted : January 22, 2010
Results First Posted : February 24, 2010
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system

Condition or disease Intervention/treatment
Sinusitis, Chronic Rhinosinusitis Device: Ethmoid Sinus Spacer

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Safety and Feasibility of the Ethmoid Sinus Spacer and Access System With Drug (SPACER)
Actual Study Start Date : April 1, 2007
Primary Completion Date : November 1, 2007
Study Completion Date : November 1, 2007
Arms and Interventions

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 Name: Acclarent Ethmoid Sinus Spacer and Access System


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054703


Locations
United States, Georgia
Georgia Nasal and Sinus Institute
Savannah, Georgia, United States, 31404
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Fred Kuhn, MD Georgia Nasal and Sinus Institute
More Information

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01054703     History of Changes
Other Study ID Numbers: CPR02082
First Posted: January 22, 2010    Key Record Dates
Results First Posted: February 24, 2010
Last Update Posted: August 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases