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| Name | Class |
|---|---|
| Somna Therapeutics, L.L.C. | INDUSTRY |
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A prospective, open label, study designed to assess the affect of the Reflux Band® UES Assist Device (Reflux Band) on reflux in patients that have undergone lung transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Transplant Patients | Experimental | For the first four weeks, lung transplant patients will not wear the Reflux Band. Use of the Reflux Band will subsequently commence in the next four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflux Band | Device | The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pepsin levels | The presence of reflux will be assessed by measuring levels of pepsin in bronchoalveolar lavage fluid. | Baseline; Week 4; Week 8 |
| Change in amylase levels | The presence of reflux will be assessed by measuring levels of amylase in bronchoalveolar lavage fluid. | Baseline; Week 4; Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Scheuble | Contact | 352-273-7589 | Vanessa.Scheuble@medicine.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Manuel Amaris, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at the University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 | Digestive System Diseases |