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SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SinuSys Corporation
ClinicalTrials.gov Identifier:
NCT02463279
First received: June 2, 2015
Last updated: December 11, 2016
Last verified: December 2016
  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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 2, 2015
Last Updated: December 11, 2016

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

ClinicalTrials.gov processed this record on May 25, 2017