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XprESS Maxillary Balloon Dilation Study

Primary Purpose

Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Balloon sinus dilation

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring Balloon sinus dilation, Balloon catheters, Sinuplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Have hemophilia.
Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region.
Have a history of cystic fibrosis.
Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis).
Have known sinonasal tumors or obstructive lesions.
Be pregnant at the time of enrollment.
Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5.
Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure.
Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Sites / Locations

Entellus Medical
Synergy ENT Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Balloon sinus dilation

Arm Description

Balloon dilation of the maxillary sinus using a transnasal approach.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recovery Time

Patient-reported time from procedure to ability to return to normal daily activities.

Procedural Pain Scores

Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant.

Revision Rate

The number of participants who require revision sinus surgery during the study duration.

Full Information

NCT ID

NCT01525862

First Posted

February 1, 2012

Last Updated

October 21, 2020

Sponsor

Entellus Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01525862

Brief Title

XprESS Maxillary Balloon Dilation Study

Official Title

XprESS Maxillary Sinus Balloon Dilation Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Entellus Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

Keywords

Balloon sinus dilation, Balloon catheters, Sinuplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Balloon sinus dilation

Arm Type

Experimental

Arm Description

Balloon dilation of the maxillary sinus using a transnasal approach.

Intervention Type

Device

Intervention Name(s)

Balloon sinus dilation

Other Intervention Name(s)

XprESS Multi-Sinus Balloon Dilation Tool

Primary Outcome Measure Information:

Title

SNOT-20 Score

Description

Time Frame

Baseline and 6 months post procedure

Secondary Outcome Measure Information:

Title

Recovery Time

Description

Patient-reported time from procedure to ability to return to normal daily activities.

Time Frame

1 week post procedure

Title

Procedural Pain Scores

Description

Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant.

Time Frame

Immediately post procedure

Title

Revision Rate

Description

The number of participants who require revision sinus surgery during the study duration.

Time Frame

6 Months post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Have hemophilia. Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region. Have a history of cystic fibrosis. Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis). Have known sinonasal tumors or obstructive lesions. Be pregnant at the time of enrollment. Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5. Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James D. Gould, MD

Organizational Affiliation

Synergy ENT Specialists

Official's Role

Principal Investigator

Facility Information:

Facility Name

Entellus Medical

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55447

Country

United States

Facility Name

Synergy ENT Specialists

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.entellusmedical.com

Description

Sponsor website

URL

https://www.stlsinuscenter.com/wp-content/uploads/2018/04/In-Office-Balloon-Dilation.Procedue-Technique-and-Outcome-Dr.-James-D.-Gould-2-copy.pdf

Description

White paper with study results

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XprESS Maxillary Balloon Dilation Study

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