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Completed

NCT Number: NCT00645762

Balloon REmodeling Antrostomy THErapy Study

This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Central California Ear, Nose and Throat Medical Group, Fresno, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects age 18 or older with chronic rhinosinusitis of the maxillary or maxillary and anterior ethmoid sinuses
  • A CT scan taken after maximal medical therapy (e.g., local or systemic antibiotics, topical steroids, etc.) must show one of the following:
  • Narrowing of the outflow tract of the maxillary sinus ostium or infundibulum with mucosal thickening of 2 mm or greater of the maxillary sinus antrum.
  • Evidence of maxillary sinus air/liquid level.

Exclusion criteria

  • Evidence of chronic posterior ethmoid, sphenoid or frontal sinusitis
  • Inability to understand the study or a history of non-compliance with medical advice
  • Unwilling or unable to sign Informed Consent Form (ICF)
  • Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies)
  • History of any cognitive or mental health status that would interfere with study participation
  • Previous sinus surgery or intervention including sinuplasty
  • Pregnant women
  • Severe septal deviation causing obstruction of the ostiomeatal unit
  • History of primary ciliary dysfunction
  • Hemophilia
  • Currently undergoing or in the past 6 months had undergone chemotherapy for cancer or radiation therapy in the head or neck region
  • History of cystic fibrosis
  • Known Sampter's Triad (aspirin sensitivity, asthma, sinonasal polyposis)
  • Known sinonasal tumors or obstructive lesions
  • History of mid facial fractures or orthognathic surgery (does not include nasal fracture)
  • History of insulin dependent diabetes
  • Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio(INR) is below 1.5
  • Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure
  • Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure
  • Presence of nasal polyps that may interfere with the treatment procedure
  • Presence of features consistent with sinus fungal disease on CT or physical examination

Treatment and study plan

RS-Series Rhinosinusitis Treatment System

Device

Single arm

FinESS Balloon

Device

Primary outcomes

  1. Incidences of Device-related or Procedure-related Complications

    Time frame: Through 12 months post-procedure

  2. Patency of the Treated Area as Verified by CT Scan

    Time frame: Post-treatment at 3 months

    Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.

  3. Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement

    Time frame: Post-treatment through 12 months

    Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful.

Sponsors and collaborators

Lead sponsor

Entellus Medical, Inc.

Industry

Registry information

Official study title

Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

Acronym: BREATHE I

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 28, 2008
Registry last updated
Jul 29, 2013

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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