NCT02502084

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: 3NT Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinusitis

Interventions

Type	Name	Description
DEVICE	3NT flexible endoscope	The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2015-07-20
• Last updated: 2017-12-22

Locations

2 sites across 2 countries: Belgium, Israel