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Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
This study has been completed.
First Received: September 30, 2005   Last Updated: December 6, 2006   History of Changes
Sponsored by: Acclarent
Information provided by: Acclarent
ClinicalTrials.gov Identifier: NCT00231062
  Purpose

A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.


Condition Intervention Phase
Chronic Sinusitis
 Device: Sinuplasty
 Phase III

MedlinePlus related topics: Sinusitis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Patency of sinus ostium after sinuplasty.
  • Adverse event rate following sinuplasty procedure.

Secondary Outcome Measures:
  • Relief of sinus symptoms.

Estimated Enrollment: 50
Study Start Date: April 2005
Estimated Study Completion Date: June 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231062

Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: xxx xxx, xx xxx
  More Information

No publications provided

Study ID Numbers: CP-00313
Study First Received: September 30, 2005
Last Updated: December 6, 2006
ClinicalTrials.gov Identifier: NCT00231062     History of Changes
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis
Sinusitis

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

ClinicalTrials.gov processed this record on May 07, 2009



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