Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD

Study Overview
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Brief Summary
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3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures

Detailed Description
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The rationale behind this feasibility study is to show that access and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in conjunction with Balloon Sinus Dilation in patients suffering from symptoms attributable to sinusitis is feasible in the office and operating room settings; This is an essential step in the development of a combined dilation and visualization system that will allow visualization, dilation and lavage of the sinuses via their natural ostia during an office visit, and minimize radiation exposure, antibiotic use, multiple office visits, and cost.

Official Title
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Safety and Effectiveness Evaluation of the Sinusway™ Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses in Conjunction With Sinus Balloon Dilation

Conditions
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Sinusitis

Intervention / Treatment
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* Device: 3NT flexible endoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient indicated for balloon sinus dilation procedure by the ENT specialist Patient age: adult (>18 years old) Patients in general good health in the opinion of the investigator as determined by medical history and physical examination A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent Exclusion Criteria: Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3NT flexible endoscope<br>Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy | Device: 3NT flexible endoscope<br>* The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation<br>* Other names: Balloon sinus dilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Device Effects | Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Sinuses Accessed and Visualized Successfully | Physician evaluation of the ability to access and visualize the paranasal sinuses. will be recorded as done/not done/failed | 1 hour | 
| User Satisfaction (1-bad, 5-good) | Physician satisfaction questionnaire (1-bad, 5-good) | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, BSD