Trial Outcomes & Findings for Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase (NCT NCT04905134)
NCT ID: NCT04905134
Last Updated: 2024-09-19
Results Overview
Measured using a 5 point scale, with 1=Very hard, 2=Harder, 3=Same, 4=Easier and 5=Very Easy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
up to 15 minutes
Results posted on
2024-09-19
Participant Flow
The providers who conducted the exams (n = 9) were not considered enrolled.
Participant milestones
| Measure |
SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract
Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about your experience with the investigational scope device compared to the routine scope exam.
|
|---|---|
|
Exam With Standard Nasopharyngoscope
STARTED
|
53
|
|
Exam With Standard Nasopharyngoscope
COMPLETED
|
50
|
|
Exam With Standard Nasopharyngoscope
NOT COMPLETED
|
3
|
|
Exam With Study Nasopharyngoscope
STARTED
|
50
|
|
Exam With Study Nasopharyngoscope
COMPLETED
|
50
|
|
Exam With Study Nasopharyngoscope
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract
Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about your experience with the investigational scope device compared to the routine scope exam.
|
|---|---|
|
Exam With Standard Nasopharyngoscope
Study device not available
|
2
|
|
Exam With Standard Nasopharyngoscope
Withdrawal by Subject
|
1
|
Baseline Characteristics
Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase
Baseline characteristics by cohort
| Measure |
SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract
n=50 Participants
Participants who meet the clinical criteria to under a nasopharyngoscope examination were asked to have an exam with the study flexible nasopharyngoscope (FNS) after the routine scope exam done as part of their standard of care. They also completed a short survey about their experience with the investigational scope device compared to the routine scope exam.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 15 minutesPopulation: Only applicable to the providers who conducted the exams.
Measured using a 5 point scale, with 1=Very hard, 2=Harder, 3=Same, 4=Easier and 5=Very Easy.
Outcome measures
| Measure |
Providers Using Flexible Nasopharyngoscope Prototype Device
n=50 Participant exams
Nasopharyngoscope: Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
|
|---|---|
|
Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use
1=Very hard
|
0 Participant exams
|
|
Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use
2=Harder
|
9 Participant exams
|
|
Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use
3=Same
|
33 Participant exams
|
|
Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use
4=Easier
|
6 Participant exams
|
|
Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use
5=Very Easy
|
2 Participant exams
|
SECONDARY outcome
Timeframe: Day 1Population: Only applicable to the providers who conducted the exams.
Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the SOC scope at each value.
Outcome measures
| Measure |
Providers Using Flexible Nasopharyngoscope Prototype Device
n=50 Participant exams
Nasopharyngoscope: Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
|
|---|---|
|
Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale
1=Poor
|
0 Participant exams
|
|
Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale
2=Fair
|
0 Participant exams
|
|
Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale
3=Good
|
0 Participant exams
|
|
Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale
4=Very Good
|
14 Participant exams
|
|
Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale
5=Excellent
|
36 Participant exams
|
SECONDARY outcome
Timeframe: Day 1Population: Only applicable to the providers who conducted the exams.
Measured using a 5 point scale where 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. Reported here is the number of participant exams in which providers scored the image quality of the flexible scope at each value.
Outcome measures
| Measure |
Providers Using Flexible Nasopharyngoscope Prototype Device
n=50 Participant exams
Nasopharyngoscope: Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
|
|---|---|
|
Image Quality of the Flexible Scope as Measured on a 5-point Scale
1=Poor
|
0 Participant exams
|
|
Image Quality of the Flexible Scope as Measured on a 5-point Scale
2=Fair
|
0 Participant exams
|
|
Image Quality of the Flexible Scope as Measured on a 5-point Scale
3=Good
|
2 Participant exams
|
|
Image Quality of the Flexible Scope as Measured on a 5-point Scale
4=Very Good
|
13 Participant exams
|
|
Image Quality of the Flexible Scope as Measured on a 5-point Scale
5=Excellent
|
35 Participant exams
|
SECONDARY outcome
Timeframe: Day 1Population: Participants who completed the study.
Outcome measures
| Measure |
Providers Using Flexible Nasopharyngoscope Prototype Device
n=50 Participants
Nasopharyngoscope: Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
|
|---|---|
|
Number of Patients Who Experienced an Adverse Event Following the Use of the Flexible Scope
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Participants who completed the study.
Comparison made using a 3 point scale where 1=much more, 2=about the same, and 3=much less.
Outcome measures
| Measure |
Providers Using Flexible Nasopharyngoscope Prototype Device
n=50 Participants
Nasopharyngoscope: Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
|
|---|---|
|
Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope
1=much more
|
6 Participants
|
|
Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope
2=about the same
|
29 Participants
|
|
Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope
3=much less
|
15 Participants
|
Adverse Events
SOC Nasopharyngoscope Examination of the Upper Aerodigestive Tract
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