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Completed

NCT Number: NCT00231062

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.

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Key information

Conditions

Chronic Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Extensive sinonasal polyps
  • Extensive previous sinonasal surgery
  • Extensive sinonasal osteoneogenesis
  • Cystic fibrosis
  • Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
  • Sinonasal tumors or obstructive lesions
  • History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
  • Ciliary dysfunction
  • Pregnant females

Treatment and study plan

Sinuplasty

Device

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 4, 2005
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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