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

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

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

Study Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Device: 3NT flexible endoscope

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94108
      • SF Otolaryngology
  • Utah
    • Salt Lake City, Utah, United States, 84403
      • Ogden Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3NT flexible endoscope; Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy	Device: 3NT flexible endoscope; The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation; Other Names: Balloon sinus dilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
User Satisfaction (1-bad, 5-good)	Physician satisfaction questionnaire (1-bad, 5-good)	1 hour

Collaborators and Investigators

• Sponsor: 3NT Medical Ltd.
• Investigators: Principal Investigator: Jacob Johnson, MD, SF Otolaryngology

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): March 21, 2018
• Study Completion (Actual): May 2, 2019

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Endoscopy, BSD
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: SD001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No