Trial Outcomes & Findings for Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease (NCT NCT03619811)
NCT ID: NCT03619811
Last Updated: 2021-09-20
Results Overview
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.
COMPLETED
NA
43 participants
Week 8 (Completion)
2021-09-20
Participant Flow
Participant milestones
| Measure |
Symptomatic
This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)
Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.
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|---|---|
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Overall Study
STARTED
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43
|
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Overall Study
COMPLETED
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31
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Overall Study
NOT COMPLETED
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12
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
Baseline characteristics by cohort
| Measure |
Symptomatic
n=43 Participants
This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)
Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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33 Participants
n=99 Participants
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Age, Categorical
>=65 years
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10 Participants
n=99 Participants
|
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Age, Continuous
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50.48 years
STANDARD_DEVIATION 15.1 • n=99 Participants
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Sex: Female, Male
Female
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26 Participants
n=99 Participants
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Sex: Female, Male
Male
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17 Participants
n=99 Participants
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Race/Ethnicity, Customized
White / Caucasian
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26 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Black
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1 Participants
n=99 Participants
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Race/Ethnicity, Customized
Asian
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2 Participants
n=99 Participants
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Race/Ethnicity, Customized
Hispanic
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10 Participants
n=99 Participants
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Race/Ethnicity, Customized
Other
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4 Participants
n=99 Participants
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Region of Enrollment
United States
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43 participants
n=99 Participants
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Reflux Symptom Index Baseline
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24.1 units on a scale
STANDARD_DEVIATION 10.9 • n=99 Participants
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PRIMARY outcome
Timeframe: Week 8 (Completion)Population: This analysis includes the participants that completed phase 1 \& 2 of the study.
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.
Outcome measures
| Measure |
Symptomatic
n=31 Participants
This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)
Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.
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|---|---|
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Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
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15.5 score on a scale
Standard Deviation 10.3
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PRIMARY outcome
Timeframe: Week 4Population: This population completed phase 1.
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.
Outcome measures
| Measure |
Symptomatic
n=36 Participants
This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)
Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.
|
|---|---|
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Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
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21.9 score on a scale
Standard Deviation 9.7
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Adverse Events
Symptomatic
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Symptomatic
n=43 participants at risk
This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)
Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.
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|---|---|
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Musculoskeletal and connective tissue disorders
Discomfort
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2.3%
1/43 • Number of events 1 • 26 months
Standard definitions of adverse event and/or serious adverse event were used to collect adverse event information.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place