Status:
COMPLETED
Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
Lead Sponsor:
3NT Medical Ltd.
Conditions:
Sinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
Detailed Description
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 Si...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
April 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03390257
Start Date
April 25 2017
End Date
May 2 2019
Last Update
December 8 2020
Active Locations (2)
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1
SF Otolaryngology
San Francisco, California, United States, 94108
2
Ogden Clinic
Salt Lake City, Utah, United States, 84403