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NCT01612780 Clinical Trial

Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Sinusitis Clinical Trial

Official title:
Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01612780
Other study ID # 2233-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2012
Est. completion date October 2013

Study information
Verified date October 2020
Source Entellus Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• XprESS Multi-Sinus Dilation Tool
Sinus balloon dilation

Locations
Country Name City State
United States Entellus Medical Plymouth Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gould J, Alexander I, Tomkin E, Brodner D. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):156-63. doi: 10.2500/ajra.2014.28.4043. Epub 2014 Feb 14. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in 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 1-year post procedure
Secondary Revision Sinus Surgery The number of participants who require revision sinus surgery to address continuing sinus symptoms. 1-year post procedure
Secondary Number of Participants With Serious Device and/or Procedure-related Adverse Events 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
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