Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

October 21, 2020 updated by: Entellus Medical, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Plymouth, Minnesota, United States, 55447
        • Entellus Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 age 18 years old or older.
  2. 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.
  3. Have a sinus CT scan within 12 months of the procedure date.
  4. Be able and willing to provide consent.
  5. Be willing to comply with the protocol requirements.

Exclusion Criteria:

  1. Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
  2. Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
  3. Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
  4. Have presence of features consistent with sinus fungal disease.
  5. Be allergic to nickel or barium sulfate.
  6. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: XprESS Multi-Sinus Dilation Tool
Balloon sinus dilation
Device: XprESS Multi-Sinus Dilation Tool
Sinus balloon dilation
Other Names:
  • Sinus balloon dilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SNOT-20 Score
Time Frame: Baseline and 1-year post procedure
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 1-year post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revision Sinus Surgery
Time Frame: 1-year post procedure
The number of participants who require revision sinus surgery to address continuing sinus symptoms.
1-year post procedure
Number of Participants With Serious Device and/or Procedure-related Adverse Events
Time Frame: Through 1-year post procedure follow-up
Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.
Through 1-year post procedure follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entellus Medical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

June 1, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (ESTIMATE)

June 6, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2233-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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