XprESS Registry Study

Not Applicable

Completed

Conditions: Sinusitis

Interventions: Device: XprESS Balloon Device

Registration Number: NCT01115309

Lead Sponsor: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 175

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XprESS Balloon Device	XprESS Balloon Device	Sinus dilation

Primary Outcome Measures

Name	Time	Method
Safety Assessments	1 month after procedure	Adverse event reporting as related to XprESS device or procedure

Secondary Outcome Measures

Name	Time	Method
Sino-Nasal Outcome Test (SNOT-20) at 1 Month	Baseline and 1 month after procedure	The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
SNOT-20 at 6 Months	Baseline and 6 months post procedure	The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
SNOT-20 at 12 Months	Baseline and 12 months post procedure	The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.