N/A
N=203
Optimization and Refinement of Technique in In-Office Sinus Dilation 2
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT01107379 ↗Enrolled (actual)
203
Serious AEs
0.5%
Results posted
Sep 2014
Primary outcome: Primary: Mean Intra-patient Change in SNOT-20 Score — -1.16 Scores on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Relieva Balloon Sinuplasty System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intra-patient Change in SNOT-20 Score |
-1.16 | — |
| PRIMARY Mean Intra-patient Change in Lund-Mackay CT Scan Score |
-4.32 | — |
| SECONDARY Procedure Tolerability |
163 | — |
| SECONDARY Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary |
552 | — |
| SECONDARY Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events. |
552 | — |
| SECONDARY Mean Number of Days to Return to Normal Activities |
2.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01107379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.