XprESS Registry Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sinusitis
- Sponsor
- Entellus Medical, Inc.
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- Safety Assessments
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Detailed Description
Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients. One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Safety Assessments
Time Frame: 1 month after procedure
Adverse event reporting as related to XprESS device or procedure
Secondary Outcomes
- Sino-Nasal Outcome Test (SNOT-20) at 1 Month(Baseline and 1 month after procedure)
- SNOT-20 at 6 Months(Baseline and 6 months post procedure)
- SNOT-20 at 12 Months(Baseline and 12 months post procedure)