Phase 2
N=71
Balloon REmodeling Antrostomy THErapy Study
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT00645762 ↗Enrolled (actual)
71
Serious AEs
1.4%
Results posted
Jul 2013
Primary outcome: Primary: Incidences of Device-related or Procedure-related Complications — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RS-Series Rhinosinusitis Treatment System (Device); FinESS Balloon (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Entellus Medical, Inc.
- Primary completion
- Jun 2010
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 | — |
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.
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.