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

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502084
• Other study ID #: 3NT-IL1
• Status: Completed
• Phase: N/A
• First received: July 13, 2015
• Last updated: December 20, 2017
• Start date: August 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2017
• Source: 3NT Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sinusitis

Intervention

Device:
• 3NT flexible endoscope
The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Israel	Assuta Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
3NT Medical Ltd.

Countries where clinical trial is conducted

Belgium,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by unanticipated device-related adverse events		During hospital stay, up to 1 day
Secondary	Performance assessed by anatomical landmarks reached and visualized will be recorded		During procedure, up to 3 hours