Efficacy of Reza Band for the Treatment of Laryngopharyngeal Reflux

May 6, 2020 updated by: John Rhee, Medical College of Wisconsin

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 tolerate an endoscopy and consent to participate in this research study will be included. The study will consist of two cohorts. Cohort one will receive standard care (n = 30), and cohort two will receive standard care plus the Reza Band (to be worn as recommended by the manufacturer; n = 30). Patients will be assigned to either of the cohorts, based on their preferences.

Two laryngeal (posterior cricoid) biopsy specimens (one for pepsin ELISA and the other for qPCR for IL -1β, -6, and -8 inflammatory cytokines) and a throat saliva sample (for pepsin ELISA) will be obtained pre- and posttreatment (12 weeks) in an ambulatory clinic setting. The RSI, a patient-reported symptom severity questionnaire, will be administered in the clinic pre- and posttreatment. (36) Patients will be instructed to cough and clear the back of their throat to provide a saliva sample prior to endoscopy. The RFS (37) will be obtained by the study physicians during office endoscopy prior to biopsy. Deidentified biopsy and saliva samples will be transported to the research laboratory on ice and stored at -80 prior to analyses by ELISA and qPCR.

Pepsin ELISA One biopsy per subject will be homogenized in urea lysis buffer and total protein concentration determined as previously described (28). Saliva samples will be cleared by brief centrifugation. Noncompetitive indirect sandwich enzyme-linked immunosorbent assay described previously (35) will be performed to detect pepsin in biopsy homogenate and saliva.

qPCR RNA will be extracted from a second biopsy, DNAsed and reverse transcribed as described (38). Real time polymerase chain reaction will be performed in a Viaa7 Real Time PCR System using Taqman Gene Expression Assays targeting IL -1β, -6, and -8, and the housekeeping gene HPRT1 (ThermoFisher Scientific, Waltham, MA).

This pilot study will pave the way for clinical trials of a much-needed therapy for airway reflux. If the hypothesis proves true and the Reza Band resolves pepsin and inflammatory cytokines, and significantly improves endoscopic signs (RFS) and symptoms (RSI) of LPR, these data will also support a clinical trial to assess the utility of the Reza Band in preventing reflux-attributed laryngeal inflammatory and neoplastic disease sequelae. To our knowledge, this is the first study that will use pepsin as a primary outcome measure; it is believed to be a sensitive and specific biomarker for reflux and aspiration.

Deidentified biopsy and saliva samples will be transported to the research laboratory on ice and stored at -80 degrees C prior to analyses by ELISA and qPCR. The tissue and saliva samples will be labeled with patient study ID number and date of collection.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical diagnosis of laryngopharyngeal reflux (LPR).
  2. Age ≥ 18 years.
  3. Reflux Finding Score (RFS) of ≥ 7 and an Reflux Symptom Index (RSI) ≥ 13.
  4. Patients should be able to tolerate an endoscopy.
  5. Patients must be deemed able to comply with the treatment plan and follow-up schedule.
  6. 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.
  7. Patients must provide study-specific informed consent prior to study entry.

Exclusion Criteria:

  1. Patient should not be on anticoagulants
  2. Currently being treated with another investigational medical device and/or drug.
  3. Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP).
  4. 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.
  5. Previous head or neck surgery or radiation.
  6. Carotid artery disease, thyroid disease or history of cerebral vascular disease.
  7. Suspected esophageal cancer.
  8. Has either a pacemaker or implanted cardioverter defibrillator (ICD).
  9. Nasopharyngeal cancer.
  10. Previously undergone Nissen Fundoplication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Group A will receive standard of care
Experimental: Reza band use
Group B will receive standard care plus the Reza band (worn as recommended by the manufacturer)
Device: Reza band
Reza band, a non-medication, non-surgical medical device designed to reduce symptoms of LPR has recently been approved by the FDA. It works by stopping the flow of gastric contents through the upper esophageal sphincter (UES) by increasing the internal pressure of the UES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tissue and Salivary Pepsin Levels
Time Frame: The change in Pepsin will be measured pre and post 12 week treatment for LPR +/- Reza band
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 change in Pepsin will be measured pre and post 12 week treatment for LPR +/- Reza band

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Study Director: Nikki Johnston, PhD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 10, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO30948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

If the decision is made to make individual participant data (IPD) available to other researchers, that data will be completely identified prior to release.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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