Trial Outcomes & Findings for Safety and Effectiveness of the Peregrine Drivable ENT Scope for Endoscopy of the Paranasal Sinuses (NCT NCT04096482)
NCT ID: NCT04096482
Last Updated: 2021-10-15
Results Overview
The ability of each endoscope type to visualize the maxillary sinus anatomy (ostium, floor, lateral recess, anterior wall) was assessed as being a success or failure.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Day 1 (after each endoscopy)
Results posted on
2021-10-15
Participant Flow
Participants were recruited from Emory University Hospital Midtown in Atlanta, Georgia, USA. Participant enrollment began November, 5, 2019 and all follow up was complete by September 1, 2020.
Participant milestones
| Measure |
Standard 30° 4mm Endoscope Followed by Peregrine Endoscope
Participants with prior endoscopic sinus surgery (EES) scheduled for nasal endoscopy who are receiving an endoscopy with the standard 30° 4mm endoscope followed by an endoscopy with the Peregrine Drivable Ear Nose and Throat (ENT) Scope.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of the Peregrine Drivable ENT Scope for Endoscopy of the Paranasal Sinuses
Baseline characteristics by cohort
| Measure |
Standard Endoscope Followed by Peregrine Drivable ENT Scope
n=6 Participants
Participants with prior endoscopic sinus surgery (EES) scheduled for nasal endoscopy who are receiving an endoscopy with the standard 30° 4mm endoscope followed by an endoscopy with the Peregrine Drivable ENT Scope.
|
|---|---|
|
Age, Continuous
|
50.83 years
STANDARD_DEVIATION 17.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (after each endoscopy)The ability of each endoscope type to visualize the maxillary sinus anatomy (ostium, floor, lateral recess, anterior wall) was assessed as being a success or failure.
Outcome measures
| Measure |
Peregrine Drivable ENT Scope
n=6 Participants
Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
|
Standard 30° 4mm Endoscope
n=6 Participants
Participants receiving an endoscopy with the standard 30° 4mm endoscope.
|
|---|---|---|
|
Number of Participants With Visualization Success of Maxillary Sinus Anatomy
Left Ostium
|
6 Participants
|
6 Participants
|
|
Number of Participants With Visualization Success of Maxillary Sinus Anatomy
Right Ostium
|
6 Participants
|
6 Participants
|
|
Number of Participants With Visualization Success of Maxillary Sinus Anatomy
Left Floor
|
6 Participants
|
1 Participants
|
|
Number of Participants With Visualization Success of Maxillary Sinus Anatomy
Right Floor
|
4 Participants
|
0 Participants
|
|
Number of Participants With Visualization Success of Maxillary Sinus Anatomy
Left Lateral Recess
|
6 Participants
|
1 Participants
|
|
Number of Participants With Visualization Success of Maxillary Sinus Anatomy
Right Lateral Recess
|
5 Participants
|
1 Participants
|
|
Number of Participants With Visualization Success of Maxillary Sinus Anatomy
Left Anterior Wall
|
6 Participants
|
0 Participants
|
|
Number of Participants With Visualization Success of Maxillary Sinus Anatomy
Right Anterior Wall
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 (after each endoscopy)The ability of each endoscope type to visualize the frontal sinus anatomy (ostium, posterior table, anterior table, lateral recess) was assessed as being a success or failure.
Outcome measures
| Measure |
Peregrine Drivable ENT Scope
n=6 Participants
Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
|
Standard 30° 4mm Endoscope
n=6 Participants
Participants receiving an endoscopy with the standard 30° 4mm endoscope.
|
|---|---|---|
|
Number of Participants With Visualization Success of Frontal Sinus Anatomy
Right Posterior Table
|
3 Participants
|
3 Participants
|
|
Number of Participants With Visualization Success of Frontal Sinus Anatomy
Left Lateral Recess
|
2 Participants
|
0 Participants
|
|
Number of Participants With Visualization Success of Frontal Sinus Anatomy
Right Lateral Recess
|
1 Participants
|
0 Participants
|
|
Number of Participants With Visualization Success of Frontal Sinus Anatomy
Left Ostium
|
6 Participants
|
6 Participants
|
|
Number of Participants With Visualization Success of Frontal Sinus Anatomy
Right Ostium
|
6 Participants
|
6 Participants
|
|
Number of Participants With Visualization Success of Frontal Sinus Anatomy
Left Posterior Table
|
4 Participants
|
3 Participants
|
|
Number of Participants With Visualization Success of Frontal Sinus Anatomy
Left Anterior Table
|
4 Participants
|
2 Participants
|
|
Number of Participants With Visualization Success of Frontal Sinus Anatomy
Right Anterior Table
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 (after each endoscopy)The ability of each endoscope type to visualize the sphenoid sinus anatomy (ostium, sella, floor, lateral aspect) was assessed as being a success or failure.
Outcome measures
| Measure |
Peregrine Drivable ENT Scope
n=6 Participants
Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
|
Standard 30° 4mm Endoscope
n=6 Participants
Participants receiving an endoscopy with the standard 30° 4mm endoscope.
|
|---|---|---|
|
Number of Participants With Visualization Success of Sphenoid Sinus Anatomy
Left Ostium
|
6 Participants
|
5 Participants
|
|
Number of Participants With Visualization Success of Sphenoid Sinus Anatomy
Right Ostium
|
6 Participants
|
6 Participants
|
|
Number of Participants With Visualization Success of Sphenoid Sinus Anatomy
Left Sella
|
4 Participants
|
5 Participants
|
|
Number of Participants With Visualization Success of Sphenoid Sinus Anatomy
Right Sella
|
4 Participants
|
5 Participants
|
|
Number of Participants With Visualization Success of Sphenoid Sinus Anatomy
Left Floor
|
3 Participants
|
3 Participants
|
|
Number of Participants With Visualization Success of Sphenoid Sinus Anatomy
Right Floor
|
5 Participants
|
3 Participants
|
|
Number of Participants With Visualization Success of Sphenoid Sinus Anatomy
Left Lateral Aspect
|
4 Participants
|
2 Participants
|
|
Number of Participants With Visualization Success of Sphenoid Sinus Anatomy
Right Lateral Aspect
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 (after each endoscopy)Image quality will be assessed through a yes/no statement, reported by physicians, regarding the adequacy of the Peregrine image quality for making clinical decisions in the office setting.
Outcome measures
| Measure |
Peregrine Drivable ENT Scope
n=6 Participants
Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
|
Standard 30° 4mm Endoscope
Participants receiving an endoscopy with the standard 30° 4mm endoscope.
|
|---|---|---|
|
Number of Participants With Adequate or Inadequate Image Quality From Peregrine Endoscopy
Adequate image quality
|
4 Participants
|
—
|
|
Number of Participants With Adequate or Inadequate Image Quality From Peregrine Endoscopy
Inadequate image quality
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (after each endoscopy)Participant tolerability was evaluated through validated VAS for both endoscopies. Scores range from 1 to 10, where 1 = highly tolerable and 10 = not tolerable.
Outcome measures
| Measure |
Peregrine Drivable ENT Scope
n=6 Participants
Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
|
Standard 30° 4mm Endoscope
n=6 Participants
Participants receiving an endoscopy with the standard 30° 4mm endoscope.
|
|---|---|---|
|
Visual Analogue Scale (VAS) Tolerability Score
|
1.98 score on a scale
Standard Deviation 1.72
|
2.52 score on a scale
Standard Deviation 3.66
|
SECONDARY outcome
Timeframe: Day 1 (after each endoscopy)Participant pain was evaluated through validated VAS for both endoscopies. Scores range from 1 to 10, where 1 = no pain and 10 = pain as bad as it could be.
Outcome measures
| Measure |
Peregrine Drivable ENT Scope
n=6 Participants
Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
|
Standard 30° 4mm Endoscope
n=6 Participants
Participants receiving an endoscopy with the standard 30° 4mm endoscope.
|
|---|---|---|
|
VAS Pain Score
|
3.75 score on a scale
Standard Deviation 1.79
|
4.13 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Day 1 (after each endoscopy)The impact on clinical workflow of visual information obtained by each endoscope procedures was rated by physicians on a 5-point scale where 1 = worst and 5 = best.
Outcome measures
| Measure |
Peregrine Drivable ENT Scope
n=6 Participants
Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
|
Standard 30° 4mm Endoscope
n=6 Participants
Participants receiving an endoscopy with the standard 30° 4mm endoscope.
|
|---|---|---|
|
Impact on Clinical Workflow
|
3 score on a scale
Standard Deviation 1.55
|
5 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 1 (after each endoscopy)The ease of use of each endoscope procedure was rated by physicians on a 5-point scale where 1 = worst and 5 = best.
Outcome measures
| Measure |
Peregrine Drivable ENT Scope
n=6 Participants
Participants receiving an endoscopy with the Peregrine Drivable ENT scope.
|
Standard 30° 4mm Endoscope
n=6 Participants
Participants receiving an endoscopy with the standard 30° 4mm endoscope.
|
|---|---|---|
|
Ease of Use
|
2.67 score on a scale
Standard Deviation 1.37
|
5 score on a scale
Standard Deviation 0
|
Adverse Events
Peregrine Drivable ENT Scope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard 30° 4mm 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place