Efficacy of Reza Band for the Treatment of Laryngopharyngeal Reflux

NCT03463395 | Withdrawn FDA Device

• 1 other identifier: PRO30948
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Laryngopharyngeal Reflux

Outcome Measures

Primary Outcomes (1)

• Change in Tissue and Salivary Pepsin Levels

  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

Study Arms (2)

Standard of Care

NO INTERVENTION

Group A will receive standard of care

Reza band use

EXPERIMENTAL

Group B will receive standard care plus the Reza band (worn as recommended by the manufacturer)

Device: Reza band

Interventions

Reza band DEVICE

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

Reza band use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Laryngopharyngeal Reflux

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Study Officials

• Nikki Johnston, PhD

  Medical College of Wisconsin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Model Details: Sixty patients ≥ 18 years of age presenting to the investigator's 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. One cohort (Group A) will receive standard care (n =30), the other (Group B) will receive standard care plus the Reza band (to be worn as recommended by the manufacturer; n = 30).

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 13, 2018
• Study Start: July 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)