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Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01107379
First received: April 12, 2010
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

A prospective, single-arm, multi-center, post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat 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)

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Change of Lund-MacKay CT scan scores and SNOT-20 scores at baseline and 24-weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and Pain scores on a visual analog scale [ Time Frame: Day 0 (Day of Procedure) ] [ Designated as safety issue: No ]
    Procedure Tolerability: Tolerability will be based on subject-reported pain during and immediately following the procedure. Pain and subject tolerability of the procedure will be reported using Visual Analog Scale (VAS) and the global assessment questionnaire.


Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: September 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Balloon device
Treatment of sinusitis using balloon tools
 Device: Relieva Balloon Sinuplasty System
Sinuplasty balloon tools for treatment of 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107379

Locations
United States, Alabama
Xxx
Birmingham, Alabama, United States, 35242
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Michael Sillers, MD Alabama Nasal and Sinus Center
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01107379     History of Changes
Other Study ID Numbers: CPR005010
Study First Received: April 12, 2010
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013