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This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.
Reflux associated laryngeal symptoms, coined "laryngopharyngeal reflux", occurs when gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat clearing, sore throat and dysphonia. Over the past 25 years, Reflux associated laryngeal symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflux Band® Upper Esophageal Sphincter (UES) Assist Device | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | 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. | Week 8 (Completion) |
| Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | 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. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
Laryngeal mass lesion on laryngoscopy;
Pregnant;
Unable to consent in English;
Imprisoned;
PPI intolerance;
Contraindication to UESAD use per manufacturer guidelines which include:
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| Name | Affiliation | Role |
|---|---|---|
| Rena Yadlapati, M.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34275061 | Derived | Yadlapati R, Pandolfino JE, Greytak M, Cahoon J, Clarke M, Clary M, Fink D, Menard-Katcher P, Vahabzadeh-Hagh AM, Weissbrod P, Gupta S, Kaizer A, Wani S. Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. Dig Dis Sci. 2022 Jul;67(7):3045-3054. doi: 10.1007/s10620-021-07172-2. Epub 2021 Jul 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | 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. | This analysis includes the participants that completed phase 1 & 2 of the study. | Posted | Mean | Standard Deviation | score on a scale | Week 8 (Completion) |
|
26 months
Standard definitions of adverse event and/or serious adverse event were used to collect adverse event information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Collar bone discomfort reported. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | UCSD | 858-246-5236 | mgreytak@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2019 | Oct 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D057045 | Laryngopharyngeal Reflux |
| D004935 | Esophageal Diseases |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Reflux Symptom Index Baseline | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | 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. | This population completed phase 1. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
|
|
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| 0 |
| 43 |
| 0 |
| 43 |
| 1 |
| 43 |
|
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| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |