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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3NT flexible endoscope | Experimental | Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3NT flexible endoscope | Device | The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by unanticipated device-related adverse events | During hospital stay, up to 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Performance assessed by anatomical landmarks reached and visualized will be recorded | During procedure, up to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University | Ghent | 9000 | Belgium | |||
| Assuta Medical Center |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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|
| Tel Aviv |
| Israel |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |