XprESS Maxillary Balloon Dilation Study

XprESS Maxillary Sinus Balloon Dilation Study

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

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Device: Balloon sinus dilation

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Plymouth, Minnesota, United States, 55447
      • Entellus Medical
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Synergy ENT Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
11. Have a history of cystic fibrosis.
12. Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis).
13. Have known sinonasal tumors or obstructive lesions.
14. Be pregnant at the time of enrollment.
15. Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5.
16. Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure.
17. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balloon sinus dilation; Balloon dilation of the maxillary sinus using a transnasal approach.	Device: Balloon sinus dilation; Other Names: XprESS Multi-Sinus Balloon Dilation Tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNOT-20 Score	The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.	Baseline and 6 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery Time	Patient-reported time from procedure to ability to return to normal daily activities.	1 week post procedure
Procedural Pain Scores	Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant.	Immediately post procedure
Revision Rate	The number of participants who require revision sinus surgery during the study duration.	6 Months post procedure

Collaborators and Investigators

• Sponsor: Entellus Medical, Inc.
• Investigators: Principal Investigator: James D. Gould, MD, Synergy ENT Specialists

Publications and helpful links

Helpful Links

• White paper with study results

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Balloon sinus dilation; Balloon catheters; Sinuplasty
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Dilatation, Pathologic
• Other Study ID Numbers: 2091-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes