Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses

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 accessing and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in patients suffering from symptoms attributable to sinusitis is feasible; This is an essential step in the development of a system that will later allow visualization, sampling, and treatment of the sinuses via the natural sinus ostium during the patient's first office visit in a minimally invasive manner while enabling treatment by lavage, and minimizing 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

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 primary FESS procedure by the ear, nose and throat (ENT) specialist Patient age: adult (>18 years old) Patients in general good health in the opinion of the investigator as determined by medical history 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: A patient with nasal polyposis A patient indicated for tumor excision 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) Pregnancy Patients with previous FESS surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 functional endoscopic sinus surgery (FESS) procedure.<br>* Other names: Sinusway;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by unanticipated device-related adverse events |  | During hospital stay, up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance assessed by anatomical landmarks reached and visualized will be recorded |  | During procedure, up to 3 hours |