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XprESS Registry Study

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ClinicalTrials.gov Identifier: NCT01115309
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : May 22, 2014
Information provided by (Responsible Party):
Entellus Medical, Inc.

Brief Summary:
This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).

Condition or disease Intervention/treatment
Sinusitis Device: XprESS Balloon Device

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: XprESS Registry Study
Study Start Date : April 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Arm Intervention/treatment
XprESS Balloon Device Device: XprESS Balloon Device
Procedure completed with the XprESS Balloon Device

Primary Outcome Measures :
  1. Safety Assessments [ Time Frame: 12 months ]
    Adverse event reporting as related to XprESS device or procedure

Secondary Outcome Measures :
  1. Quality of Life Questionnaire Completion [ Time Frame: 12 months ]
    Use of Sino-Nasal Outcome Test 20 Questionnarie and Rhinosinusitis Symptom Investory Questionnarie completed by subjects pre and post procedure.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older
  • Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
  • Willing and able to provide consent

Exclusion Criteria:

  • Known Samter's Triad
  • History of primary ciliary dysfunction
  • History of cystic fibrosis
  • Known to be immunosuppressed
  • Hemophilia
  • Currently enrolled in another pre-approval investigational study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115309

United States, Texas
Texas Sinus Center
San Antonio, Texas, United States, 78006
Sponsors and Collaborators
Entellus Medical, Inc.
Study Chair: Jeff Grebner Entellus Medical

Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01115309     History of Changes
Other Study ID Numbers: 1677-001
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by Entellus Medical, Inc.:

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases