Status:
WITHDRAWN
Efficacy of Reza Band for the Treatment of Laryngopharyngeal Reflux
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Laryngopharyngeal Reflux
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, an...
Detailed Description
We propose a prospective cohort study. Sixty patients ≥ 18 years of age presenting to our laryngology outpatient clinic with LPR, with an RFS ≥ 7 and an RSI ≥ 13, not on anticoagulants, able to tolera...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03463395
Start Date
July 1 2020
End Date
November 1 2021
Last Update
May 8 2020
Active Locations (1)
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1
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226