72 Participants Needed

Reflux Band for Acid Reflux

ER
ER
CR
Overseen ByClinical Research Administrator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
Must be taking: Acid suppression therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the idea that Reflux Band for Acid Reflux is an effective treatment?

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 rabeprazole and pantoprazole, which are shown to be effective in relieving symptoms and healing damage caused by acid reflux. These drugs are compared to other treatments, such as H2-receptor antagonists, which are less effective in severe cases. However, there is no direct comparison or data on the Reflux Band in the provided information.12345

What safety data exists for the Reflux Band treatment for acid reflux?

The provided research does not contain specific safety data for the Reflux Band or Reza Band treatment for acid reflux. The studies focus on severe cutaneous adverse reactions to drugs and do not mention the Reflux Band or similar devices. Therefore, no relevant safety data for this treatment is available in the provided research.678910

Is the Reflux Band a promising treatment for acid reflux?

The provided research articles do not mention the Reflux Band or Reza Band as a treatment for acid reflux. They focus on various drugs and therapies for gastroesophageal reflux disease (GERD), such as vonoprazan, lesogaberan, and AZD0865, which are different from the Reflux Band. Therefore, based on the given information, we cannot determine if the Reflux Band is a promising treatment for acid reflux.511121314

How is the Reflux Band treatment different from other acid reflux treatments?

The Reflux Band is unique because it is a non-drug treatment that works by applying gentle pressure to the throat to prevent stomach acid from rising, unlike medications that reduce acid production.511121314

What is the purpose of this trial?

This trial tests if a special neck band can help people with throat issues caused by stomach acid. The band is worn at night and works by increasing pressure on a muscle to stop acid from reaching the throat.

Research Team

RY

Rena Yadlapati, MD, MSHS

Principal Investigator

UC San Diego Health

Eligibility Criteria

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.
See 4 more

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.
See 14 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Participants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines.
Group II: ControlPlacebo Group1 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

Find a Clinic Near You

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+

Findings from Research

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.
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 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.
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.
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]

References

Rabeprazole for the prevention of recurrent erosive or ulcerative gastro-oesophageal reflux disease. Rabeprazole Study Group. [2019]
Effects of rabeprazole on early symptom relief in gastro-oesophageal reflux disease: the Hellenic Rabeprazole Study Group surveillance study. [2013]
Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. [2019]
Pharmacological management of gastro-oesophageal reflux disease. [2018]
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. [2014]
Severe cutaneous adverse reactions to drugs: A real-world pharmacovigilance study using the FDA Adverse Event Reporting System database. [2023]
Individual case safety reports in children in commonly used drug groups - signal detection. [2021]
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. [2019]
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. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Delayed Cutaneous Hypersensitivity Reactions to Antibiotics: Management with Desensitization. [2018]
A study for every second day administration of vonoprazan for maintenance treatment of erosive GERD (ESD von GERD): a multicenter randomized cross-over study. [2022]
Pharmacokinetic profile of lesogaberan (AZD3355) in healthy subjects: a novel GABA(B)-receptor agonist reflux inhibitor. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
A randomized, comparative study of three doses of AZD0865 and esomeprazole for healing of reflux esophagitis. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Combination drug therapy for gastroesophageal reflux disease. [2017]
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