What side effects are associated with this type of intervention?

Common treatments for acid reflux include proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), and antacids. PPIs can cause side effects such as headache, diarrhea, constipation, and an increased risk of fractures with long-term use. H2RAs may lead to headaches, dizziness, and an increased risk of enteric infections like C. difficile. Antacids can cause constipation or diarrhea, depending on their ingredients, and long-term use may lead to electrolyte imbalances. The External Upper Esophageal Band, which provides external pressure to the upper esophageal sphincter to prevent reflux, may cause discomfort or difficulty swallowing, but specific side effects are not well-documented and require further study.

What prior FDA approvals exist?

The FDA has approved several treatments for acid reflux, including proton pump inhibitors (PPIs) like omeprazole and esomeprazole, and H2 receptor antagonists (H2RAs) such as ranitidine and famotidine. These medications reduce stomach acid production and are commonly used for GERD management. Additionally, surgical options like Nissen fundoplication, which reinforces the lower esophageal sphincter, have been approved. While the External Upper Esophageal Band is a novel approach providing external pressure to the upper esophageal sphincter to prevent reflux, it is not yet a standard FDA-approved treatment. Current FDA-approved treatments focus more on acid suppression and surgical reinforcement of the lower esophageal sphincter.

What other types of research exist?

Promising novel alternatives to the External Upper Esophageal Band for acid reflux patients include: 1) Laparoscopic Nissen fundoplication, which has shown efficacy in curing refractory GERD as diagnosed by impedance-pH monitoring. 2) Self-expandable metal stents with an antireflux valve, such as the FerX-Ella stent, which have been effective in preventing gastroesophageal reflux in patients with tumors of the distal esophagus or gastric cardia. 3) Doubling the dose of proton pump inhibitors (PPIs) or using alternative medications like alginate-based formulations for patients with refractory heartburn. 4) Minimally invasive procedures and lifestyle modifications, including diet changes, diaphragmatic breathing, and transcutaneous electrical acustimulation, which may benefit patients with esophageal hypersensitivity or functional symptoms.

← Back to Search

Other

Shaker Pressure Band for GERD

N/A

Recruiting

Led By Reza Shaker

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up initial physician assessment and after one week of treatment

Summary

This trial is testing a device placed around the upper esophagus to help patients with severe reflux symptoms that don't respond to other treatments. The device works by increasing pressure to stop acid from moving up into the throat.

Who is the study for?

Adults aged 18 or older with GERD and related ear, nose, throat symptoms, chronic cough, choking, or regurgitation can join. They must not be pregnant or breastfeeding and have no history of head/neck surgery or radiation. Excluded are those under 18 or over 85, with sleep apnea (on CPAP), carotid artery/thyroid/cerebral vascular disease, bleeding disorders preventing nasal intubation, or esophageal obstruction.

What is being tested?

The trial is testing the Shaker Pressure Band's effectiveness in reducing nighttime symptoms caused by acid reflux into the pharynx. It aims to see if this external upper esophageal band can provide relief for patients suffering from GERD-related discomfort at night.

What are the potential side effects?

Potential side effects are not specified for the Shaker Pressure Band intervention; however common concerns may include discomfort where the band is applied and possible skin irritation due to prolonged use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ initial physician assessment and after one week of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~initial physician assessment and after one week of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and initial physician assessment and after one week of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Symptom Analysis

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Shaker Pressure Band GERD patients with external laryngeal pressureActive Control1 Intervention

One week of Shaker pressure band

Group II: Shaker Pressure Band GERD patients without external laryngeal pressurePlacebo Group1 Intervention

One week of sham Shaker pressure band (no external laryngeal pressure)

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for acid reflux include proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), prokinetics, and mechanical interventions like the external upper esophageal band. PPIs work by blocking the enzyme responsible for acid production in the stomach, thereby reducing acid levels and preventing reflux. H2RAs reduce acid production by blocking histamine receptors in the stomach lining. Prokinetics enhance gastrointestinal motility, helping to clear stomach contents more efficiently and reduce reflux episodes. The external upper esophageal band provides external pressure to the upper esophageal sphincter, preventing acid from traveling back into the esophagus. These treatments are crucial for acid reflux patients as they help manage symptoms, prevent esophageal damage, and improve quality of life.

Rumination, heartburn, and daytime gastroesophageal reflux. A case study with mechanisms defined and successfully treated with biofeedback therapy.Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease.Risk factors for erosive reflux esophagitis: a case-control study.