Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)

Integra LifeSciences

Status: Completed

Conditions: Sinusitis

Treatments: Device: Relieva Balloon Sinuplasty System

Study type: Observational

Funder types: Industry

Identifiers

NCT01107379

CPR005010

Details and patient eligibility

About

A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/Female, 18 year or older
• Diagnosis of Chronic Rhinosinusitis
• Planned Endoscopic Sinus surgery

Exclusion criteria

• Cystic Fibrosis
• Severe Polyposis
• Sinonasal tumors
• History of facial trauma precluding access to sinus ostium
• Ciliary Disfunction
• Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.)
• Pregnant or lactating female
• Inability to tolerate an awake procedure
• Participation in another investigational clinical study involving treatment for chronic rhinosinusitis

Trial design

203 participants in 1 patient group

Balloon catheter device

Description:

Dilation of sinuses using Relieva Balloon Sinuplasty System

Treatment:

Device: Relieva Balloon Sinuplasty System