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

This study has been completed.
Sponsor:
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT00231062
First received: September 30, 2005
Last updated: June 10, 2011
Last verified: June 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

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: Christopher Church, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Laura England, Manager-Clinical Affairs, Acclarent, Inc.
ClinicalTrials.gov Identifier: NCT00231062     History of Changes
Other Study ID Numbers: CP-00313
Study First Received: September 30, 2005
Results First Received: April 29, 2011
Last Updated: June 10, 2011
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

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 April 16, 2014