N/A
N=82
Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT01612780 ↗Enrolled (actual)
82
Serious AEs
1.2%
Results posted
Oct 2020
Primary outcome: Primary: Change in SNOT-20 Score — 2.3; 0.7 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- XprESS Multi-Sinus Dilation Tool (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Entellus Medical, Inc.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in SNOT-20 Score |
2.3; 0.7 | <0.0001 sig |
| SECONDARY Revision Sinus Surgery |
1 | — |
| SECONDARY Number of Participants With Serious Device and/or Procedure-related Adverse Events |
— | — |
Summary
The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.
Eligibility Criteria
Inclusion Criteria
- Be at least age 18 years old or older.
- Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.
- Have a sinus CT scan within 12 months of the procedure date.
- Be able and willing to provide consent.
- Be willing to comply with the protocol requirements.
Exclusion Criteria
- Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
- Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
- Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
- Have presence of features consistent with sinus fungal disease.
- Be allergic to nickel or barium sulfate.
- Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.
Data sourced from ClinicalTrials.gov (NCT01612780). 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.