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

Completed · Not applicable

Conditions studied: Sinusitis

In brief

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

Key facts

Study ID

NCT03390257

Run by

3NT Medical Ltd.

People needed

14

Starts

2017-04-25

Expected to finish

2019-05-02

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• SF Otolaryngology — San Francisco, California, United States
• Ogden Clinic — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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