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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

September 30, 2005
June 10, 2011
April 2005
June 2006   (final data collection date for primary outcome measure)
  • 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).
  • Patency of sinus ostium after sinuplasty.
  • Adverse event rate following sinuplasty procedure.
Complete list of historical versions of study NCT00231062 on ClinicalTrials.gov Archive Site
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.
Relief of sinus symptoms.
Not Provided
Not Provided
 
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

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

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Sinusitis
Device: Sinuplasty
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
June 2006
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00231062
CP-00313
Yes
Laura England, Manager-Clinical Affairs, Acclarent, Inc.
Acclarent
Not Provided
Principal Investigator: Christopher Church, MD Loma Linda University
Acclarent
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP