XprESS Registry Study

Entellus Medical

Status: Completed

Conditions: Sinusitis

Treatments: Device: XprESS Balloon Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01115309

1677-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 1 patient group

XprESS Balloon Device

Other group

Description:

Sinus dilation

Treatment:

Device: XprESS Balloon Device