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

Sinusitis Clinical Trial

Official title:

Safety and Effectiveness Evaluation of the Sinusway™ Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses in Conjunction With Sinus Balloon Dilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390257
• Other study ID #: SD001
• Status: Completed
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: May 2, 2019

Study information

• Verified date: October 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2, 2019
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sinusitis

Intervention

Device:
• 3NT flexible endoscope
The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation

Locations

Country	Name	City	State
United States	Ogden Clinic	Salt Lake City	Utah
United States	SF Otolaryngology	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
3NT Medical Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Device Effects	Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy	4 hours
Secondary	Percent of Sinuses Accessed and Visualized Successfully	Physician evaluation of the ability to access and visualize the paranasal sinuses. will be recorded as done/not done/failed	1 hour
Secondary	User Satisfaction (1-bad, 5-good)	Physician satisfaction questionnaire; (1-bad, 5-good)	1 hour