Efficacy of Reza Band for the Treatment of Laryngopharyngeal Reflux

Withdrawn before enrolling · Not applicable

Conditions studied: Laryngopharyngeal Reflux

In brief

We hypothesize that tissue and salivary pepsin will resolve after 12 weeks use of Reza Band, but not following standard of care alone. Additionally, RFS, RSI and inflammatory cytokines (IL -1β, -6, and -8) will decrease to normative levels following 12 weeks use of Reza Band, but not with standard of care alone. Primary Objective The primary objective is to evaluate the efficacy of the Reza Band for the treatment of LPR. We propose a pilot clinical trial to test the hypothesis that the Reza Band is effective for the treatment of LPR, measured by resolution of pepsin and decrease to normative values for RSI, Reflux Finding Score (RFS) and inflammatory cytokines. The long-term goal is to determine the efficacy of the Reza Band in the sequential progression of reflux-attributed laryngeal inflammatory and neoplastic disease.

Key facts

Study ID

NCT03463395

Run by

Medical College of Wisconsin

People needed

0

Starts

2020-07-01

Expected to finish

2021-11-01

Last updated by the study team

2020-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of laryngopharyngeal reflux (LPR).
• Age ≥ 18 years.
• Reflux Finding Score (RFS) of ≥ 7 and an Reflux Symptom Index (RSI) ≥ 13.
• Patients should be able to tolerate an endoscopy.
• Patients must be deemed able to comply with the treatment plan and follow-up schedule.
• Enrollment on an interventional postoperative study is allowed if study device/agents do not overlap i.e. no other investigational device or medication for the treatment of LPR is permitted during the duration of this study.
• Patients must provide study-specific informed consent prior to study entry.

You may not qualify if…

• Patient should not be on anticoagulants
• Currently being treated with another investigational medical device and/or drug.
• Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP).
• The patient is female and is of childbearing potential and is not using an acceptable method of birth control or is pregnant or breast-feeding.
• Previous head or neck surgery or radiation.
• Carotid artery disease, thyroid disease or history of cerebral vascular disease.
• Suspected esophageal cancer.
• Has either a pacemaker or implanted cardioverter defibrillator (ICD).
• Nasopharyngeal cancer.
• Previously undergone Nissen Fundoplication.

Where it is running

• Froedtert Hospital and Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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