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XprESS Registry Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Entellus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01115309
First received: April 29, 2010
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Sinusitis
 Device: XprESS Balloon Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: XprESS Registry Study

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Further study details as provided by Entellus Medical, Inc.:

Primary Outcome Measures:
  • Safety Assessments [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse event reporting as related to XprESS device or procedure


Secondary Outcome Measures:
  • Quality of Life Questionnaire Completion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Use of Sino-Nasal Outcome Test 20 Questionnarie and Rhinosinusitis Symptom Investory Questionnarie completed by subjects pre and post procedure.


Enrollment: 175
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
XprESS Balloon Device Device: XprESS Balloon Device
Procedure completed with the XprESS Balloon Device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115309

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

No publications provided

Responsible Party: Entellus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01115309     History of Changes
Other Study ID Numbers: 1677-001
Study First Received: April 29, 2010
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Entellus Medical, Inc.:
Sinusitis

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

ClinicalTrials.gov processed this record on May 19, 2013