Reflux Band for Acid Reflux

Overseen By Clinical Research Administrator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: Acid suppression therapy

Disqualifiers: Asthma, COPD, Pregnant, Tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Reflux Band, a device worn externally to manage acid reflux by applying pressure to the upper esophagus. The goal is to determine if this device can reduce symptoms such as chronic throat clearing, persistent cough, or sore throat in individuals with laryngopharyngeal reflux (LPR), a type of acid reflux affecting the throat. Participants will be divided into two groups: one using the device as intended and another using a version that does not apply effective pressure. The trial seeks individuals who have experienced these symptoms for at least eight weeks and are already using strong acid-reducing medications. As an unphased trial, this study offers a unique opportunity to explore a new approach to managing LPR symptoms.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on a double daily dose acid suppression therapy, so you may need to continue those medications.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires participants to be on a double daily dose of acid suppression therapy. It seems likely you will continue your current acid reflux medications during the trial.

What prior data suggests that the Reflux Band is safe for treating acid reflux?

Research has shown that the Reflux Band, an external device used to ease symptoms of laryngopharyngeal reflux (LPR), is generally safe for individuals aged 18 and older. The Reflux Band gently presses on the neck to prevent stomach acid from rising into the throat.

Although specific safety data from studies is lacking, the FDA has approved the device to help reduce LPR symptoms, indicating it is safe when used as instructed.

In earlier studies, users of the Reflux Band reported fewer symptoms such as constant throat irritation, coughing, and a hoarse voice. These results suggest that the device is well-tolerated with few side effects. However, discussing any safety concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for acid reflux, such as proton pump inhibitors and H2 blockers, the Reflux Band offers a unique approach by physically compressing the upper esophageal sphincter (UES) to prevent acid from escaping the stomach. This mechanical method is distinct because it doesn't rely on altering stomach acid production, which can lead to side effects or take time to show results. Researchers are excited about the Reflux Band because it promises immediate relief by directly addressing the physical cause of reflux, potentially benefiting patients who don't respond to traditional medications.

What evidence suggests that the Reflux Band is effective for acid reflux?

Research has shown that the Reflux Band may help with laryngopharyngeal reflux (LPR), a condition where stomach acid irritates the throat. One study found that 86% of people using the Reflux Band experienced a significant reduction in symptoms after just two weeks. Another study found it effective when used alongside medications like proton pump inhibitors (PPIs), which lower stomach acid. In this trial, participants in the experimental arm will use the Reflux Band, which works by gently pressing on the muscle at the top of the esophagus, preventing acid from rising and causing irritation. This device has relieved symptoms like a hoarse voice, chronic throat irritation, and cough. ^{1 3 4 5 6}

Who Is on the Research Team?

Rena Yadlapati, MD, MSHS

Principal Investigator

UC San Diego Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-99 with laryngopharyngeal reflux confirmed by tests, who have been on double dose acid suppression therapy. They must not have had neck cancer/surgery, use certain night-time breathing aids, or have specific conditions like glaucoma or a history of foregut surgery. Pregnant/breastfeeding individuals and those unable to consent in English/Spanish are excluded.

Inclusion Criteria

This criterion means that you need to meet at least one of the listed requirements.

I have had symptoms like voice changes or sore throat for over 8 weeks.

My fasting pepsin level was 25 ng/mL or higher recently.

Exclusion Criteria

I have carotid artery disease, uncontrolled thyroid disease, a history of stroke, or Marfan's/Ehlers-Danlos Syndrome.

My mental status may be altered due to sedatives or narcotics.

I have had cancer or surgery in my neck area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Reflux Band or a sham device for 8 weeks, wearing it nightly while sleeping

8 weeks

3-4 visits (in-person), 2 visits (virtual)

Unblinded Period

Participants continue using the device in an unblinded manner for 4 weeks

4 weeks

1 visit (virtual), 1 visit (in-person)

Optional Extension

Participants may opt into a 4-week extension where the Reflux Band is refit to provide the manufacturer's specified pressure

4 weeks

1 visit (virtual), 1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reflux Band

Trial Overview The study compares an external device that compresses the upper esophageal sphincter (Reflux Band) against a sham device over 12 weeks to see if it reduces symptoms of acid reflux more effectively. Participants will be randomly assigned to either the real treatment or placebo without knowing which one they receive.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Participants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines.

Group II: Control Placebo Group 1 Intervention

Participants allocated to the control arm will be fit with the UES Compression Device at a pressure known not to provide intervention.

Reflux Band is already approved in United States, European Union for the following indications:

Approved in United States as Reflux Band for:

• Laryngopharyngeal reflux (LPR) disease

Approved in European Union as Reflux Band for:

• Laryngopharyngeal reflux (LPR) disease

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study of 244 patients with persistent gastro-oesophageal reflux disease (GORD) symptoms despite proton pump inhibitor (PPI) therapy, lesogaberan (65 mg twice daily) significantly improved symptoms compared to placebo, with 16% of patients responding to treatment versus 8% in the placebo group.

Lesogaberan was well tolerated, with mild to moderate adverse events reported in 45% of patients taking lesogaberan compared to 37% on placebo, indicating it is a safe add-on therapy for GORD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Boeckxstaens, GE., Beaumont, H., Hatlebakk, JG., et al.[2014]

Desensitization to mild to moderate delayed skin reactions caused by antibiotics has been successfully achieved and is considered safe, although it has only been documented for a limited number of antibiotics.

There is a significant need to create standardized protocols for managing delayed cutaneous adverse reactions to antibiotics to improve treatment consistency and patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed Cutaneous Hypersensitivity Reactions to Antibiotics: Management with Desensitization. McNulty, CMG., Park, MA.[2018]

A study analyzing drug safety reports for children under 15 revealed that the frequency of adverse drug reactions varies significantly across different drug groups, with reports ranging from 0 to 24 per million defined daily doses.

Montelukast, a leukotriene receptor antagonist, showed a particularly high number of reports, especially in children under 5, indicating potential psychiatric side effects that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual case safety reports in children in commonly used drug groups - signal detection. Brunlöf, G., Tukukino, C., Wallerstedt, SM.[2021]

In a study of 19 patients with severe cutaneous adverse reactions (AA-SCARs) to antibiotics, combined in vivo and ex vivo testing successfully identified the causative antibiotic in 79% of cases, demonstrating the effectiveness of these diagnostic approaches.

The ex vivo testing showed a high specificity of 100% and improved sensitivity of 75% when conducted shortly after the onset of reactions, allowing for safer antibiotic choices in patients with confirmed drug causality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Combined Utility of Ex Vivo IFN-γ Release Enzyme-Linked ImmunoSpot Assay and In Vivo Skin Testing in Patients with Antibiotic-Associated Severe Cutaneous Adverse Reactions. Trubiano, JA., Strautins, K., Redwood, AJ., et al.[2019]

Rabeprazole at doses of 10 mg and 20 mg significantly reduced the relapse rate of gastro-oesophageal reflux disease (GORD) compared to placebo, with relapse rates of 23% and 14% respectively, versus 71% for placebo after 52 weeks.

Both doses of rabeprazole were well tolerated, with most side effects being mild or moderate, and no significant adverse effects on vital signs or laboratory tests, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rabeprazole for the prevention of recurrent erosive or ulcerative gastro-oesophageal reflux disease. Rabeprazole Study Group. Birbara, C., Breiter, J., Perdomo, C., et al.[2019]

In a study of 122 patients, vonoprazan administered every second day showed significantly better control of GERD symptoms compared to lansoprazole, with 93.6% of patients well controlled versus 82.1% for lansoprazole (P = 0.003).

The results suggest that vonoprazan is a promising alternative to proton pump inhibitors (PPIs) for maintaining treatment of erosive GERD, as it demonstrated superior symptom control and effectiveness over a 4-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study for every second day administration of vonoprazan for maintenance treatment of erosive GERD (ESD von GERD): a multicenter randomized cross-over study. Matsuda, S., Kato, M., Sakakibara, Y., et al.[2022]

AZD0865, an acid-suppressing agent, demonstrated similar healing rates for reflux esophagitis compared to esomeprazole after 4 weeks of treatment, with healing rates around 76.9% to 81.1% for AZD0865 and 81.9% for esomeprazole.

Both AZD0865 and esomeprazole were well-tolerated, although some patients on the highest dose of AZD0865 experienced reversible increases in liver enzymes, indicating a need for monitoring at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, comparative study of three doses of AZD0865 and esomeprazole for healing of reflux esophagitis. Kahrilas, PJ., Dent, J., Lauritsen, K., et al.[2022]

In a clinical study involving 272 patients with gastro-oesophageal reflux disease (GORD), rabeprazole provided significant symptom relief within the first week, particularly improving heartburn and regurgitation by day 1.

Rabeprazole also demonstrated high efficacy in healing oesophageal erosions, with 77% of patients achieving healing by week 4 and 90% by week 8, while the treatment was well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of rabeprazole on early symptom relief in gastro-oesophageal reflux disease: the Hellenic Rabeprazole Study Group surveillance study. Archimandritis, AJ., Nikolopoulou, V., Kouklakis, G., et al.[2013]

In a study of 209 patients with mild gastro-oesophageal reflux disease (GERD), low-dose pantoprazole (20 mg) provided significantly faster relief from symptoms compared to ranitidine (300 mg), with 69% of patients reporting complete relief after 2 weeks versus 48% for ranitidine.

Pantoprazole also demonstrated superior healing of GERD lesions, with 80% of patients showing healing after 4 weeks compared to 64% in the ranitidine group, indicating its greater efficacy in treating mild GERD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. Dettmer, A., Vogt, R., Sielaff, F., et al.[2019]

Proton pump inhibitors (PPIs) are the most effective treatment for healing reflux oesophagitis, especially in severe cases, and they can maintain remission in nearly all patients with gastro-oesophageal reflux disease (GORD) for up to 5 years, indicating a strong safety profile during this period.

For milder forms of GORD, symptom relief can often be achieved with lifestyle changes and over-the-counter medications like antacids, while prokinetic drugs like cisapride and H2-receptor antagonists can help, but PPIs are preferred for more effective healing and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological management of gastro-oesophageal reflux disease. Klinkenberg-Knol, EC., Festen, HP., Meuwissen, SG.[2018]

Lesogaberan is rapidly absorbed when taken orally, reaching peak plasma concentration within 1-2 hours, and has a terminal half-life of 11 to 13 hours, indicating effective pharmacokinetics for potential symptom relief in gastroesophageal reflux disease.

The majority of lesogaberan is excreted through the kidneys, either as the unchanged drug or as metabolites, with no safety concerns reported during the study involving 10 healthy male subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic profile of lesogaberan (AZD3355) in healthy subjects: a novel GABA(B)-receptor agonist reflux inhibitor. Niazi, M., Skrtic, S., Ruth, M., et al.[2021]

A study analyzing 62 FDA-approved drugs from 2006 to 2010 found that most adverse event (AE) reporting in the FAERS database does not follow the 'Weber effect,' which suggested a peak in reporting two years post-approval.

Instead of a peak, the data showed a consistent increase in AE reports during the first three quarters after drug approval, indicating improvements in reporting practices and awareness by the FDA since the original Weber effect was described.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Weber effect and the United States Food and Drug Administration's Adverse Event Reporting System (FAERS): analysis of sixty-two drugs approved from 2006 to 2010. Hoffman, KB., Dimbil, M., Erdman, CB., et al.[2021]

Approximately 80-90% of patients with gastroesophageal reflux disease (GERD) heal from reflux esophagitis after 8 weeks of once-daily proton-pump inhibitor (PPI) therapy, but up to 70% still experience nocturnal acid breakthrough even with twice-daily PPI therapy.

Current evidence suggests that adding histamine(2) receptor antagonists, like ranitidine, to PPI therapy does not provide additional benefits for controlling nocturnal acid breakthrough or improving GERD symptoms, indicating that further research is needed to optimize treatment for patients who do not respond to standard PPI doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination drug therapy for gastroesophageal reflux disease. Cross, LB., Justice, LN.[2017]

A comprehensive analysis of 77,789 reports from the FDA Adverse Event Reporting System identified lamotrigine, acetaminophen, and allopurinol as the most reported drugs associated with severe cutaneous adverse reactions (SCARs), highlighting the need for awareness of these medications' risks.

The study found that 1,219 different drugs were implicated in SCARs, with antineoplastics being the largest drug class, and 776 drugs showed positive signals for SCARs, indicating significant safety concerns that can guide clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe cutaneous adverse reactions to drugs: A real-world pharmacovigilance study using the FDA Adverse Event Reporting System database. Li, D., Gou, J., Zhu, J., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03463395?cond=%22Laryngopharyngeal%20Reflux%22&viewType=Table&rank=4

Study Details | NCT03463395 | Efficacy of Reza Band for ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8286644/

Upper Esophageal Sphincter Compression Device as an ... This study aimed to assess device efficacy as an adjunct to proton pump inhibitor (PPI) therapy in patients with laryngopharyngeal reflux (LPR).

3. withpower.com withpower.com/trial/phase-laryngopharyngeal-reflux-4-2021-15ac6

Reflux Band for Acid Reflux · Info for Participants The available research does not provide specific data on the effectiveness of the Reflux Band for Acid Reflux. Instead, it focuses on various drugs like ...

4. gds-medtech.com gds-medtech.com/wp-content/uploads/2015/04/REZA-BAND-Doctor-Prescribe-Sheet-GDS.pdf

REZA BAND By stopping reflux from rising above the UES, the REZA BAND reduces challenging symptoms such as chronic throat irritation and cough, hoarse voice, difficulty.

5. empr.com empr.com/home/news/non-surgical-device-approved-for-acid-reflux-control/

Non-Surgical Device Approved for Acid Reflux Control - MPR In the study, 86% of patients using the Reza Band experienced a significant reduction in symptoms after 2 weeks. Physician satisfaction with the ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/K173934.pdf

K173934 510k Summary - accessdata.fda.gov The Reza Band and the Reflux Band are for people 18 years and older to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing ...