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

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

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.

Study Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Device: Relieva Balloon Sinuplasty System

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Nevada
    • Las Vegas, Nevada, United States
  • Ohio
    • Dublin, Ohio, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with diagnosis of CRS and planned endoscopic sinus surgery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Balloon catheter device; Dilation of sinuses using Relieva Balloon Sinuplasty System	Device: Relieva Balloon Sinuplasty System; Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intra-patient Change in SNOT-20 Score	Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.	Baseline and 24 weeks
Mean Intra-patient Change in Lund-Mackay CT Scan Score	Change in Lund-Mackay CT score for paired baseline and 24 week data. The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.	Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Tolerability	Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.	Day 0 (Day of Procedure)
Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary	Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary	Day 0 (Day of Procedure)
Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.	Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.	Day 0 (Day of Procedure)
Mean Number of Days to Return to Normal Activities	Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living	2 weeks

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Acclarent
• Investigators: Principal Investigator: Michael Sillers, MD, Alabama Alabama Nasal and Sinus Center

Publications and helpful links

General Publications

• Karanfilov B, Silvers S, Pasha R, Sikand A, Shikani A, Sillers M; ORIOS2 Study Investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013 May;3(5):404-11. doi: 10.1002/alr.21112. Epub 2012 Nov 7.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimated): April 21, 2010

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: CPR005010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No