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OpenTrials
Completed

NCT Number: NCT02463279

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.

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Upland ENT, Upland, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinusys Dilation System

Device

Dilation of frontal recess and/or sphenoid sinus ostia

Primary outcomes

  1. 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 outcomes

  1. Patency of treated target site

    Time frame: 1 month and 3 months

    Patency assessed by investigator via endoscopic evaluation of the target site

  2. Reports of sinus related adverse events during the 3 months follow-up period

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

SinuSys Corporation

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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