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

3NT Medical

Status: Completed

Conditions: Sinusitis

Treatments: Device: 3NT flexible endoscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT03390257

SD001

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

3NT flexible endoscope

Experimental group

Description:

Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy

Treatment:

Device: 3NT flexible endoscope