CompletedNot Applicable

XprESS Maxillary Balloon Dilation Study

United States21 participantsStarted 2011-12

Plain-language summary

A prospective, single-arm, post approval pilot study.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Be at least 18 years of age.
✓. Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.
✓. Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis.
✓. Have a CT scan within 6 months prior to enrollment.
✓. Be mentally and physically capable (as per physician discretion) to participate in the investigation.
✓. Be willing and able to sign the study-specific informed consent prior to any study-related procedures.
✓. Be willing and able to undergo balloon dilation in the clinic setting.

✕. Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.
✕. Have presence of features consistent with sinus fungal disease.
✕. Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.
✕. Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).
✕. Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).
✕. Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment.
✕. Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract.
✕. Have a history of primary ciliary dysfunction.

SNOT-20 Score

Timeframe: Baseline and 6 months post procedure

NCT IDNCT01525862

SponsorEntellus Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-01

Results submitted2020-09-29

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Be at least 18 years of age.
✓. Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.
✓. Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis.
✓. Have a CT scan within 6 months prior to enrollment.
✓. Be mentally and physically capable (as per physician discretion) to participate in the investigation.
✓. Be willing and able to sign the study-specific informed consent prior to any study-related procedures.
✓. Be willing and able to undergo balloon dilation in the clinic setting.

✕. Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.
✕. Have presence of features consistent with sinus fungal disease.
✕. Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.
✕. Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).
✕. Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).
✕. Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment.
✕. Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract.
✕. Have a history of primary ciliary dysfunction.