Phase 2
Completed N=71
Balloon REmodeling Antrostomy THErapy Study
Source: ClinicalTrials.gov NCT00645762 ↗Enrolled (actual)
71
Serious AEs
1.4%
Results posted
Jul 2013
Primary outcomePrimary: Incidences of Device-related or Procedure-related Complications — 1 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidences of Device-related or Procedure-related Complications |
1 | — |
| PRIMARY Patency of the Treated Area as Verified by CT Scan |
106 | — |
| PRIMARY Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement |
-1.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00645762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.