Healthcare Utilization and Outcomes of FinESS Treatment in the Office (RELIEF)

Entellus Medical

Status: Completed

Conditions: Rhinosinusitis

Treatments: Device: FinESS Sinus Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00986830

1630-001

Details and patient eligibility

About

A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.

Full description

A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office. Also to demonstrate the long-term durability of FinESS Sinus Treatment performed in an office setting.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Male or female subjects
• Diagnosis of rhinosinusitis (CT radiographic evidence and medical evaluation)
• Willing to comply with protocol requirements
• Able to provide consent

Exclusion criteria

• Hemophilia
• Cystic fibrosis
• Ciliary dysfunction
• Severe septal deviation causing obstruction of the ostiomeatal unit
• Pregnant females

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Balloon Dilation

Experimental group

Description:

Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.

Treatment:

Device: FinESS Sinus Treatment