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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01107379
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : September 18, 2014
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Sinusitis Device: Relieva Balloon Sinuplasty System

Study Type : Observational
Actual Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
Study Start Date : April 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

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

Primary Outcome Measures :
  1. Mean Intra-patient Change in SNOT-20 Score [ Time Frame: Baseline and 24 weeks ]

    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.

  2. Mean Intra-patient Change in Lund-Mackay CT Scan Score [ Time Frame: Baseline and 24 weeks ]

    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.

Secondary Outcome Measures :
  1. Procedure Tolerability [ Time Frame: Day 0 (Day of Procedure) ]
    Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.

  2. Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary [ Time Frame: Day 0 (Day of Procedure) ]
    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

  3. Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events. [ Time Frame: Day 0 (Day of Procedure) ]
    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.

  4. Mean Number of Days to Return to Normal Activities [ Time Frame: 2 weeks ]
    Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects with diagnosis of CRS and planned endoscopic sinus surgery.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01107379

United States, Alabama
Birmingham, Alabama, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, Ohio
Dublin, Ohio, United States
Sponsors and Collaborators
Principal Investigator: Michael Sillers, MD Alabama Alabama Nasal and Sinus Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Acclarent Identifier: NCT01107379     History of Changes
Other Study ID Numbers: CPR005010
First Posted: April 21, 2010    Key Record Dates
Results First Posted: September 18, 2014
Last Update Posted: September 18, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases