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

NCT03390257 | Completed Results FDA Device

• 1 other identifier: SD001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Sinusitis

Keywords

Endoscopy, BSD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percent of Sinuses Accessed and Visualized Successfully

  1 hour

• User Satisfaction (1-bad, 5-good)

  1 hour

Study Arms (1)

3NT flexible endoscope

EXPERIMENTAL

Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy

Device: 3NT flexible endoscope

Interventions

3NT flexible endoscope DEVICE

The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation

Also known as: Balloon sinus dilation

3NT flexible endoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient indicated for balloon sinus dilation procedure by the ENT specialist
• Patient age: adult (\>18 years old)
• Patients in general good health in the opinion of the investigator as determined by medical history and 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• 3NT Medical Ltd.: lead

Study Sites (2)

SF Otolaryngology

San Francisco, California, 94108, United States

Location

Ogden Clinic

Salt Lake City, Utah, 84403, United States

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Jacob Johnson
• Organization: SF Otolaryngology

jjohnson@sfotomed.com

4153625443

Study Officials

• Jacob Johnson, MD

  SF Otolaryngology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 4, 2018
• Study Start: April 25, 2017
• Primary Completion: March 21, 2018
• Study Completion: May 2, 2019
• Last Updated: December 8, 2020
• Results First Posted: December 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)