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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01107379
First received: April 12, 2010
Last updated: September 13, 2014
Last verified: September 2014
  Purpose

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 Intervention
Sinusitis
Device: Relieva Balloon Sinuplasty System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Mean Intra-patient Change in SNOT-20 Score [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

    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.


  • Mean Intra-patient Change in Lund-Mackay CT Scan Score [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

    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:
  • Procedure Tolerability [ Time Frame: Day 0 (Day of Procedure) ] [ Designated as safety issue: No ]
    Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.

  • 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) ] [ Designated as safety issue: No ]
    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

  • Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events. [ Time Frame: Day 0 (Day of Procedure) ] [ Designated as safety issue: Yes ]
    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.

  • Mean Number of Days to Return to Normal Activities [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living


Enrollment: 203
Study Start Date: April 2010
Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107379

Locations
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
Acclarent
Investigators
Principal Investigator: Michael Sillers, MD Alabama Alabama Nasal and Sinus Center
  More Information

No publications provided by Acclarent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01107379     History of Changes
Other Study ID Numbers: CPR005010
Study First Received: April 12, 2010
Results First Received: May 28, 2014
Last Updated: September 13, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014