Trial Outcomes & Findings for Assessing the Impacts of a UESAD on Laryngeal Symptoms and Salivary Pepsin (NCT NCT02552966)
NCT ID: NCT02552966
Last Updated: 2020-02-26
Results Overview
Average salivary pepsin concentration
COMPLETED
NA
20 participants
2 weeks
2020-02-26
Participant Flow
Subjects were recruited from the Northwestern Medicine Gastroenterology clinic during the study period beginning 9/1/2015. A total of 15 subjects
Participant milestones
| Measure |
UESAD
Upper Esophageal Sphincter Assist Device
UESAD: Device designed to provide modest cricoid pressure to reduce reflux
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
UESAD
Upper Esophageal Sphincter Assist Device
UESAD: Device designed to provide modest cricoid pressure to reduce reflux
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Assessing the Impacts of a UESAD on Laryngeal Symptoms and Salivary Pepsin
Baseline characteristics by cohort
| Measure |
UESAD
n=20 Participants
Upper Esophageal Sphincter Assist Device
UESAD: Device designed to provide modest cricoid pressure to reduce reflux
|
|---|---|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Age, Continuous
|
45.7 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
|
GERDQ
|
10.4 units on a scale
STANDARD_DEVIATION 2.1 • n=99 Participants
|
|
Reflux Symptom Index (RSI)
|
26.0 units on a scale
STANDARD_DEVIATION 7.8 • n=99 Participants
|
|
NGSSIQ
|
43.4 units on a scale
STANDARD_DEVIATION 20.1 • n=99 Participants
|
|
Pepsin (ng/mL)
|
146.5 ng/mL
STANDARD_DEVIATION 172.7 • n=99 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Twelve subjects provided post-treatment salivary samples for pepsin analysis. While the subject flow shows 20 subjects (all of which completed baseline pepsin analysis), only 12 completed post-treatment testing.
Average salivary pepsin concentration
Outcome measures
| Measure |
UESAD
n=12 Participants
Upper Esophageal Sphincter Assist Device
UESAD: Device designed to provide modest cricoid pressure to reduce reflux
|
|---|---|
|
Salivary Pepsin Concentration
|
158.4 ng/mL
Standard Deviation 150.2
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 15 subjects completed the RSI post-treatment. The subject flow shows 20 subjects completing this questionnaire at baseline, but this section reflects the 15 subjects who completed this questionnaire post-treatment.
Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity.
Outcome measures
| Measure |
UESAD
n=15 Participants
Upper Esophageal Sphincter Assist Device
UESAD: Device designed to provide modest cricoid pressure to reduce reflux
|
|---|---|
|
RSI Score
|
19.4 units on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Fifteen subjects completed the post-treatment GERDQ questionnaire. While 20 subjects completed the questionnaire at baseline, this section contains results from the 15 who completed the questionnaire 2 weeks post UESAD treatment.
GERDQ score. Scale of 0-12, higher score indicates increased symptom severity.
Outcome measures
| Measure |
UESAD
n=15 Participants
Upper Esophageal Sphincter Assist Device
UESAD: Device designed to provide modest cricoid pressure to reduce reflux
|
|---|---|
|
GerdQ Score
|
8.6 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Fifteen subjects completed the post-treatment questionnaire. While 20 subjects (as indicated on the participant flow section) completed the baseline questionnaire, this section reflects the results of the 15 subjects who completed the questionnaire at 2 weeks post UESAD treatment.
NGSSI questionnaire score
Outcome measures
| Measure |
UESAD
n=15 Participants
Upper Esophageal Sphincter Assist Device
UESAD: Device designed to provide modest cricoid pressure to reduce reflux
|
|---|---|
|
NGSSIQ Score
|
26.8 units on a scale
Standard Deviation 20.8
|
Adverse Events
UESAD
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. John Pandolfino, Principal Investigator
Northwestern University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place