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

3NT Medical

Status: Completed

Conditions: Sinusitis

Treatments: Device: 3NT flexible endoscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT02502084

3NT-IL1

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 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient indicated for primary FESS procedure by the ear, nose and throat (ENT) specialist
• Patient age: adult (>18 years old)
• Patients in general good health in the opinion of the investigator as determined by medical history 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 criteria

• A patient with nasal polyposis
• A patient indicated for tumor excision
• 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)
• Pregnancy
• Patients with previous FESS surgery

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 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