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XprESS Maxillary Balloon Dilation Study | Clinical Trials | Clareo Health

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XprESS Maxillary Balloon Dilation Study

XprESS Maxillary Sinus Balloon Dilation Study

NCT01525862•Entellus Medical, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

This study is evaluating transnasal sinus balloon dilation without tissue removal to treat the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic improvement post procedure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be at least 18 years of age.
•2. Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.
•3. 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.
•4. Have a CT scan within 6 months prior to enrollment.
•5. Be mentally and physically capable (as per physician discretion) to participate in the investigation.
•6. Be willing and able to sign the study-specific informed consent prior to any study-related procedures.
•7. Be willing and able to undergo balloon dilation in the clinic setting.

Exclusion Criteria

•1. Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.
•2. Have presence of features consistent with sinus fungal disease.
•3. Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.
•4. Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).
•5. Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).
•6. Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment.
•7. Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract.
•8. Have a history of primary ciliary dysfunction.
•9. Have hemophilia.
•10. Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region.
+7 more criteria

Locations (2)

Entellus Medical

Plymouth, Minnesota, United States

Synergy ENT Specialists

St Louis, Missouri, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

January 1, 2013

Completion Date

January 1, 2013

Last Updated

November 10, 2020

Enrollment

ACTUAL participants

Conditions

Chronic SinusitisChronic Rhinosinusitis (Diagnosis)

Interventions

Balloon sinus dilation

DEVICE

Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

NCT05427695

Chronic Rhinosinusitis (Diagnosis)

View study

ACTIVE_NOT_RECRUITING

The Sinonasal Microbiome

NCT06822725

Sinonasal DisorderChronic Rhinosinusitis (Diagnosis)

View study

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Functional Endoscopic Sinus Surgery Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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XprESS Maxillary Balloon Dilation Study

Inclusion Criteria

Exclusion Criteria

Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

The Sinonasal Microbiome

Functional Endoscopic Sinus Surgery Study

Post-operative Pain Control With Acetaminophen and Ibuprofen After Functional Endoscopic Sinus Surgery

Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)

Balloon Sinus Dilation In Office or OR