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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: May 20, 2014
Last verified: May 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Entellus Medical, Inc.:
Sinusitis

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

ClinicalTrials.gov processed this record on November 20, 2014