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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02502084
• Date of registration: 13/07/2015
• Prospective Registration: Yes
• Primary sponsor: 3NT Medical Ltd.
• Public title: Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
• Scientific title: Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
• Date of first enrolment: August 2015
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02502084
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Israel

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sinusitis

Intervention(s)

Device: 3NT flexible endoscope

Primary Outcome(s)

Safety assessed by unanticipated device-related adverse events [Time Frame: During hospital stay, up to 1 day]

Secondary Outcome(s)

Performance assessed by anatomical landmarks reached and visualized will be recorded [Time Frame: During procedure, up to 3 hours]

Secondary ID(s)

3NT-IL1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors