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

NCT01107379 | Completed Results

• 1 other identifier: CPR005010
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 3

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.

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (2)

• Mean Intra-patient Change in SNOT-20 Score

  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.

  Baseline and 24 weeks

• Mean Intra-patient Change in Lund-Mackay CT Scan Score

  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.

  Baseline and 24 weeks

Secondary Outcomes (4)

• Procedure Tolerability

  Day 0 (Day of Procedure)

• Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary

  Day 0 (Day of Procedure)

• Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.

  Day 0 (Day of Procedure)

• Mean Number of Days to Return to Normal Activities

  2 weeks

Study Arms (1)

Balloon catheter device

Dilation of sinuses using Relieva Balloon Sinuplasty System

Device: Relieva Balloon Sinuplasty System

Interventions

Relieva Balloon Sinuplasty System DEVICE

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

Balloon catheter device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male/Female, 18 year or older
• Diagnosis of Chronic Rhinosinusitis
• Planned Endoscopic Sinus surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (3)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Dublin, Ohio, United States

Location

Related Publications (1)

• Karanfilov B, Silvers S, Pasha R, Sikand A, Shikani A, Sillers M; ORIOS2 Study Investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013 May;3(5):404-11. doi: 10.1002/alr.21112. Epub 2012 Nov 7.

  PMID: 23136057 DERIVED

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Director
• Organization: Acclarent, Inc.

lenglan1@its.jnj.com

650-687-5888

Study Officials

• Michael Sillers, MD

  Alabama Alabama Nasal and Sinus Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 21, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 6, 2024
• Results First Posted: September 18, 2014

Record last verified: 2024-07

Locations

US (3)