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NCT Number: NCT01107379

Optimization and Refinement of Technique in In-Office Sinus Dilation 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.

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relieva Balloon Sinuplasty System

Device

Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

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

Acronym: ORIOS 2

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 21, 2010
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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