Balloon Sinus Dilation In Office or OR (ORIOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT00939393
First received: July 14, 2009
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.


Condition Intervention
Chronic Sinusitis
Device: FESS instruments with or without balloon treatment
Device: Balloon Sinuplasty

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: ESS Performed in Operating Room Versus Clinician's Office

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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.


Secondary Outcome Measures:
  • Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks] [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Proportion of Participants Rating Procedure as Tolerable (IO Only) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable.

  • Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity.

  • Mean Number of Debridements Per Participant (IO Only) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement.

  • Proportion of Participants With Revisions (IO Only) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure.

  • Proportion of Participants With Post-operative Sinus Infections [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS).

  • Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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 SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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 SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to 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.


Enrollment: 72
Study Start Date: April 2008
Study Completion Date: July 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FESS in OR with or without balloons
Functional Endoscopy Sinus Surgery
Device: FESS instruments with or without balloon treatment
Intervention with metal instruments with or without balloon treatment
Active Comparator: Balloon sinuplasty in physician office
Balloon Sinuplasty in physician office using Acclarent devices
Device: Balloon Sinuplasty
Balloon dilatation of sinuses

Detailed Description:

In this study, endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with the balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices. Both primary treatment of sinusitis as well as revision of previously treated sinuses will be allowed. Resource absorption will be evaluated for both venues.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years and greater
  2. Both male and female patients eligible
  3. Diagnosis of chronic sinusitis that is not responsive to medical management (> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on CT scan)
  4. Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)

Exclusion Criteria:

  1. Cystic fibrosis
  2. Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
  3. Sinonasal tumors or obstructive lesions
  4. History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
  5. Ciliary dysfunction
  6. Pregnant females
  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: NCT00939393

Locations
United States, Ohio
Rockside Road Surgery Center
Independence, Ohio, United States, 44131
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Howard Levine, MD Rockside Road Surgery Center Independence, OH
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT00939393     History of Changes
Other Study ID Numbers: CPR005002
Study First Received: July 14, 2009
Results First Received: May 6, 2014
Last Updated: September 29, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014