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Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00231062
First Posted: October 4, 2005
Last Update Posted: July 8, 2011
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:
Acclarent
  Purpose
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.

Condition Intervention Phase
Chronic Sinusitis Device: Sinuplasty Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Number of Sinuses With Patency of Sinus Ostium After Sinuplasty [ Time Frame: 24 weeks ]
    Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.

  • Number of Participants With Adverse Events Following Sinuplasty Procedure [ Time Frame: 24 weeks ]
    Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).


Secondary Outcome Measures:
  • Number of Participants Experiencing Relief of Sinus Symptoms [ Time Frame: Week 24 ]
    To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated.


Enrollment: 115
Study Start Date: April 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. Patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, loss of the sense of smell and malaise. Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity.

The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal, Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years and greater
  2. Both male and female patients eligible
  3. Diagnosis of chronic sinusitis that is not responsive to medical management
  4. Planned endoscopic sinus surgery (recommended by PI, consented to by patient)

Exclusion Criteria:

  1. Extensive sinonasal polyps
  2. Extensive previous sinonasal surgery
  3. Extensive sinonasal osteoneogenesis
  4. Cystic fibrosis
  5. Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
  6. Sinonasal tumors or obstructive lesions
  7. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
  8. Ciliary dysfunction
  9. Pregnant 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): NCT00231062


Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Christopher Church, MD Loma Linda University
  More Information

Responsible Party: Laura England, Manager-Clinical Affairs, Acclarent, Inc.
ClinicalTrials.gov Identifier: NCT00231062     History of Changes
Other Study ID Numbers: CP-00313
First Submitted: September 30, 2005
First Posted: October 4, 2005
Results First Submitted: April 29, 2011
Results First Posted: July 8, 2011
Last Update Posted: July 8, 2011
Last Verified: June 2011

Keywords provided by Acclarent:
sinusitis
rhinitis
sinus surgery
maxillary
ethmoid
sphenoid
frontal
FESS
sinuplasty

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