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COMPLETEDNANCT02463279

SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients w...

Lead sponsor: SinuSys Corporation•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

SinuSys Corporation

A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Diagnosis of CRS
•Subject in in need of frontal recess and/or sphenoid sinus dilation

Exclusion Criteria

•Pregnant or breastfeeding females
•Previous treatment site intervention
•Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 13, 2016Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment30

Start dateApr 2015

Last updatedDec 13, 2016

Condition

Locations shown

Upland ENT

Upland, California

Colorado ENT

Denver, Colorado

St. Elizabeth Medical Center

Brighton, Massachusetts

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2016Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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