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CLEAR Study

The Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Study is an international, multi-center, non-randomized, prospective evaluation for tracking safety and efficacy of the Relieva Balloon Sinuplasty™ system. Data has been published at 6 months, 1 year, and 2 years.

6 Month Study

Methodology

  • Prospective, multi-center evaluation (9 centers)
  • Clinical assessment
    • Nasal endoscopy
    • Sino-Nasal Outcomes Test (SNOT-20)
    • Clinical evaluation at 1, 12, and 24 weeks

Study Group

  • N = 115 patients (358 peripheral sinuses)
  • Patients that had previously failed medical therapy and for whom ESS was recommended

Results

  • No serious adverse events
  • 80.5% overall sinus patency
  • Revision rates:
    • 0.98% (3/307) sinuses
    • 2.75% (3/109) patients
  • Statistically significant improvement in patient symptoms

Conclusions

  • Balloon catheter technology has a satisfactory safety profile
  • Balloon catheter sinusotomy offers an effective minimally invasive treatment option to relieve sinus obstruction
  • Patients experienced improvements in symptoms
  • Longer-term follow-up is warranted

1 Year Study

Methodology

  • Prospective, multicenter evaluation (7 centers)
  • Clinical assessment
    • Nasal endoscopy
    • CT Scan
    • Sino-Nasal Outcomes Test (SNOT-20)

Study Group

  • N = 70 patients (217 peripheral sinuses)

Results

  • No serious adverse events
  • 91.6% overall functional sinus patency
  • Statistically significant improvement Lund-Mackay CT scores
  • Statistically and clinically significant improvement in SNOT-20 scores

Conclusions

  • Endoscopic sinus surgery using balloon catheter technology is effective and durable
  • One year results for balloon catheter sinusotomy compare favorably with standard endoscopic sinus surgical results
  • Balloon catheters have a place in sinusitis management

2 Year Study

Methodology

  • Prospective, multicenter evaluation (6 centers)
  • Clinical assessment
    • CT Scan
    • Sino-Nasal Outcomes Test (SNOT-20)
    • Standardized patient questionnaire

Study Group

  • N = 65patients (195 peripheral sinuses)

Results

  • No serious adverse events reported were reported between one year and two years in 65 study patients
  • Revision rates at two years
    • 3.6% sinus revision rate (7/195)
    • 9.2% patient revision rate (6/65)
  • Statistically and clinically significant improvement in SNOT-20 scores
  • Patient Questionnaire
    • Postoperative changes in symptoms
      • Improvement = 85%
      • Same = 15%
      • Worsened = 0%
    • 90% of patients would recommend balloon catheter surgery to their family and friends

Conclusions

  • Balloon catheter sinusotomy achieves a statistically significant and clinically significant improvement in SNOT-20 symptom scores at each time point through two years
  • Patients reported clinical symptom improvement across the two-years period supporting the changes in the SNOT-20 scores
  • Resolution of disease on CT Scan previously observed at one year is also sustained in this two year analysis

The results of these studies confirm other published peer-reviewed studies showing that use of Relieva Balloon Sinuplasty instruments in sinus surgery is safe and effective and improved patients’ quality of life. Patient satisfaction with this minimally invasive technology is consistently positive across the two years after surgery.

  • Bolger, W., et al, Otolaryngol Head Neck Surg 2007; 137: 10-20.
  • Kuhn, F., et al, Otolaryngol Head Neck Surg 2008; 139: S27-S37.
  • Weiss, R., et al, Otolaryngol Head Neck Surg 2008; 139: S38-S46.
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