Back to resultsStudy to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
Primary Purpose
Sinusitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3NT flexible endoscope
Sponsored by
About this trial
This is an interventional diagnostic trial for Sinusitis focused on measuring Endoscopy, BSD
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- SF Otolaryngology
- Ogden Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3NT flexible endoscope
Arm Description
Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy
Outcomes
Primary Outcome Measures
Number of Adverse Device Effects
Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy
Secondary Outcome Measures
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
User Satisfaction (1-bad, 5-good)
Physician satisfaction questionnaire
(1-bad, 5-good)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03390257
Brief Title
Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
March 21, 2018 (Actual)
Study Completion Date
May 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3NT Medical Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
Endoscopy, BSD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3NT flexible endoscope
Arm Type
Experimental
Arm Description
Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy
Intervention Type
Device
Intervention Name(s)
3NT flexible endoscope
Other Intervention Name(s)
Balloon sinus dilation
Intervention Description
The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation
Primary Outcome Measure Information:
Title
Number of Adverse Device Effects
Description
Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Percent of Sinuses Accessed and Visualized Successfully
Description
Physician evaluation of the ability to access and visualize the paranasal sinuses. will be recorded as done/not done/failed
Time Frame
1 hour
Title
User Satisfaction (1-bad, 5-good)
Description
Physician satisfaction questionnaire
(1-bad, 5-good)
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Johnson, MD
Organizational Affiliation
SF Otolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
SF Otolaryngology
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
Facility Name
Ogden Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
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