Trial Outcomes & Findings for Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD (NCT NCT03390257)

Results Overview

Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

4 hours

Results posted on

2020-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	3NT Flexible Endoscope Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy 3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3nt Flexible Endoscope n=14 Participants The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation
Age, Continuous	56.6 years n=14 Participants
Sex: Female, Male Female	5 Participants n=14 Participants
Sex: Female, Male Male	9 Participants n=14 Participants
Region of Enrollment United States	14 Participants n=14 Participants

PRIMARY outcome

Timeframe: 4 hours

Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy

Outcome measures

Outcome measures
Measure	3NT Flexible Endoscope n=14 Participants Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy 3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation No Adverse events were reported during this study.
Number of Adverse Device Effects	0 events

SECONDARY outcome

Timeframe: 1 hour

Physician evaluation of the ability to access and visualize the paranasal sinuses. will be recorded as done/not done/failed

Outcome measures

Outcome measures
Measure	3NT Flexible Endoscope n=14 Participants Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy 3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation No Adverse events were reported during this study.
Percent of Sinuses Accessed and Visualized Successfully Maxillary sinus	60.5 percentage of sinuses
Percent of Sinuses Accessed and Visualized Successfully Frontal sinus	100 percentage of sinuses
Percent of Sinuses Accessed and Visualized Successfully Sphenoid sinus	68.5 percentage of sinuses

SECONDARY outcome

Timeframe: 1 hour

Physician satisfaction questionnaire (1-bad, 5-good)

Outcome measures

Outcome measures
Measure	3NT Flexible Endoscope n=14 Participants Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy 3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation No Adverse events were reported during this study.
User Satisfaction (1-bad, 5-good) Ease of use	4.4 score on a scale 1-5 Standard Deviation 0.5
User Satisfaction (1-bad, 5-good) Lavage	4.5 score on a scale 1-5 Standard Deviation 0.52
User Satisfaction (1-bad, 5-good) Tolerability to patient	4.6 score on a scale 1-5 Standard Deviation 1.13
User Satisfaction (1-bad, 5-good) Maxillary sinus access	4.8 score on a scale 1-5 Standard Deviation 0.44
User Satisfaction (1-bad, 5-good) Frontal sinus access	4.6 score on a scale 1-5 Standard Deviation 0.52
User Satisfaction (1-bad, 5-good) Sphenoid sinus access	4.7 score on a scale 1-5 Standard Deviation 0.52
User Satisfaction (1-bad, 5-good) Image quality	4 score on a scale 1-5 Standard Deviation 0.39

Adverse Events

3NT Flexible Endoscope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacob Johnson

SF Otolaryngology

Phone: 4153625443

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place