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



Status:Recruiting
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:1/6/2018
Start Date:April 25, 2017
End Date:July 2018
Contact:Ehud Bendory
Email:ehud@3ntmedical.com
Phone:972544657761

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Safety and Effectiveness Evaluation of the Sinusway™ Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses in Conjunction With Sinus Balloon Dilation

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 access and visualization of the
nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in conjunction
with Balloon Sinus Dilation in patients suffering from symptoms attributable to sinusitis is
feasible in the office and operating room settings; This is an essential step in the
development of a combined dilation and visualization system that will allow visualization,
dilation and lavage of the sinuses via their natural ostia during an office visit, and
minimize radiation exposure, antibiotic use, multiple office visits, and cost.

Inclusion Criteria:

1. Male or female patient indicated for balloon sinus dilation procedure by the ENT
specialist

2. Patient age: adult (>18 years old)

3. Patients in general good health in the opinion of the investigator as determined by
medical history and physical examination

4. 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:

1. Known history of any significant medical disorder, which in the investigator's
judgment contraindicates the patient's participation

2. Patients with known current or previous bleeding disorder receiving anticoagulants
(e.g., chronic Coumadin treatment)
We found this trial at
2
sites
450 Sutter Street
San Francisco, California 94108
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from
San Francisco, CA
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975 Chambers Street
Salt Lake City, Utah 84403
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Salt Lake City, UT
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