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SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02463279
First Posted: June 4, 2015
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SinuSys Corporation
  Purpose
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.

Condition Intervention
Sinusitis Device: Sinusys Dilation System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

Resource links provided by NLM:


Further study details as provided by SinuSys Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: April 2015
Study Completion Date: March 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SinuSys Dilation System
Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)
Device: Sinusys Dilation System
Dilation of frontal recess and/or sphenoid sinus ostia

Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463279


Locations
United States, California
Upland ENT
Upland, California, United States, 91786
United States, Colorado
Colorado ENT
Denver, Colorado, United States, 80210
United States, Massachusetts
St. Elizabeth Medical Center
Brighton, Massachusetts, United States, 02135
Sponsors and Collaborators
SinuSys Corporation
Investigators
Study Director: Jerome Hester, MD SinuSys Chief Medical Officer
  More Information

Responsible Party: SinuSys Corporation
ClinicalTrials.gov Identifier: NCT02463279     History of Changes
Other Study ID Numbers: SNS-006
First Submitted: June 2, 2015
First Posted: June 4, 2015
Last Update Posted: December 13, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases