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
  Purpose

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


Condition Intervention
Sinusitis, Chronic Rhinosinusitis
Device: Ethmoid Sinus Spacer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: April 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Laura England, Manager- Clinical Affairs, Acclarent, Inc.
ClinicalTrials.gov Identifier: NCT01054703     History of Changes
Other Study ID Numbers: CPR02082
Study First Received: January 20, 2010
Results First Received: February 8, 2010
Last Updated: June 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014