CompletedNot Applicable

Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

United States82 participantsStarted 2012-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Change in SNOT-20 Score

Timeframe: Baseline and 1-year post procedure

Trial details

NCT IDNCT01612780

SponsorEntellus Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-10

Results submitted2020-09-29

View on ClinicalTrials.gov More Sinusitis trials