Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease



Status:Recruiting
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 89
Updated:8/11/2018
Start Date:July 13, 2018
End Date:July 31, 2021
Contact:Zoe Van Doorde, B.A.
Email:ZOE.VANDEVOORDE@UCDENVER.EDU
Phone:303-724-9228

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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.

Inclusion Criteria:

- Reflux Associated Laryngeal Symptoms (RALS) Subject Cohort:

- Age 18-89 years male and female,

- >8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness,

- naïve to PPI or able to stop for 8 weeks,

- Laryngoscopy performed within 3 months without any laryngeal mass.

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:

- Patients with implants or implant parts that reside in the area where UESAD is
applied.

- Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD),
vagus nerve stimulator, or other such similar devices implanted in the neck.

- Patients diagnosed with glaucoma.

- Patients who had a malignancy of the neck, including neck surgery.

- Patients that may have an altered mental status including due to the use of
sedative drugs or narcotics.

- Patients with carotid artery disease, thyroid disease, a history of
cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's
Syndrome or Ehlers-Danlos Syndrome).

- Patients who use nocturnal NIV machines such as CPAP or BiPAP.
We found this trial at
1
site
13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
Phone: 303-724-9228
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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Aurora, CO
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