Sinusitis
Conditions
Brief summary
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
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.
Interventions
DEVICE3NT flexible endoscope
The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.
Sponsors
3NT Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessed by unanticipated device-related adverse events | During hospital stay, up to 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Performance assessed by anatomical landmarks reached and visualized will be recorded | During procedure, up to 3 hours |
Countries
Belgium, Israel
Outcome results
None listed