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SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

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ClinicalTrials.gov Identifier: NCT02463279
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
SinuSys Corporation

June 2, 2015
June 4, 2015
December 13, 2016
April 2015
October 2015   (Final data collection date for primary outcome measure)
Patency of treated target site [ Time Frame: Patency immediately post device expansion and removal ]
Patency assessed by investigator via endoscopic evaluation of the target site
Not Provided
Complete list of historical versions of study NCT02463279 on ClinicalTrials.gov Archive Site
  • Patency of treated target site [ Time Frame: 1 month and 3 months ]
    Patency assessed by investigator via endoscopic evaluation of the target site
  • Reports of sinus related adverse events during the 3 months follow-up period [ Time Frame: up to 3 months ]
Not Provided
Not Provided
Not Provided
 
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
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 with chronic rhinosinusitis.
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).
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sinusitis
Device: Sinusys Dilation System
Dilation of frontal recess and/or sphenoid sinus ostia
Experimental: SinuSys Dilation System
Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)
Intervention: Device: Sinusys Dilation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
March 2016
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02463279
SNS-006
No
Not Provided
Not Provided
SinuSys Corporation
SinuSys Corporation
Not Provided
Study Director: Jerome Hester, MD SinuSys Chief Medical Officer
SinuSys Corporation
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP