350 Participants Needed

Shaker Pressure Band for GERD

RS
MK
Overseen ByMark Kern
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical College of Wisconsin

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the Shaker Pressure Band treatment for GERD differ from other treatments?

The Shaker Pressure Band is unique because it likely involves a physical or mechanical approach to managing GERD, unlike common treatments like medications or lifestyle changes. This could offer an alternative for those who do not respond well to traditional therapies.12345

What data supports the effectiveness of the Shaker Pressure Band treatment for GERD?

The Reflux Band, a similar device that compresses the upper esophageal sphincter, has been shown to reduce reflux events when used alongside standard medication for laryngopharyngeal reflux, suggesting potential benefits for GERD as well.24678

Who Is on the Research Team?

Reza Shaker, MD | Froedtert & the ...

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are not pregnant or breastfeeding.
You have GERD and experience symptoms such as chronic cough, choking, or food coming back up into your throat.
Patients with gastroesophageal reflux disease (GERD) who has ear, nose, and throat symptoms, chronic cough, choking, or regurgitation (food coming back up into the throat)
See 3 more

Exclusion Criteria

Patient cannot have previous head or neck surgery or radiation
The patient cannot have sleep apnea or be on CPAP
Patient cannot have carotid artery disease, thyroid disease or history of cerebral vascular disease
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the Shaker pressure band or a sham band for one week

1 week
1 visit (in-person) for band fitting and assessment

Follow-up

Participants are monitored for changes in symptoms after treatment

1 week
1 visit (in-person) for symptom evaluation

What Are the Treatments Tested in This Trial?

Interventions

  • Shaker Pressure Band
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Shaker Pressure Band GERD patients with external laryngeal pressureActive Control1 Intervention
Group II: Shaker Pressure Band GERD patients without external laryngeal pressurePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Published Research Related to This Trial

In a clinical trial with 31 participants, the Reflux Band device, when used alongside proton pump inhibitors (PPIs), significantly improved symptoms of laryngopharyngeal reflux (LPR), with 55% of participants meeting the primary endpoint after 4 weeks of combined treatment.
The study found that the mean reflux symptom index (RSI) score significantly decreased from 21.9 after PPI alone to 15.5 after using the Reflux Band with PPI, indicating enhanced efficacy of the device in reducing reflux symptoms.
Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux.Yadlapati, R., Pandolfino, JE., Greytak, M., et al.[2022]
In a study of 5796 patients with gastro-oesophageal reflux disease (GERD), approximately 14-20% experienced a partial response to proton pump inhibitors (PPIs), indicating that while PPIs are effective for many, some patients still have significant heartburn symptoms.
Partial heartburn response was more common in patients with non-erosive reflux disease (19.9%) compared to those with reflux oesophagitis (14.0%), suggesting that the type of reflux disease may influence treatment outcomes.
Partial symptom-response to proton pump inhibitors in patients with non-erosive reflux disease or reflux oesophagitis - a post hoc analysis of 5796 patients.Bytzer, P., van Zanten, SV., Mattsson, H., et al.[2022]
The North American Society for Pediatric Gastroenterology and Nutrition has developed a clinical practice guideline for managing gastroesophageal reflux (GER) and gastroesophageal reflux disease (GERD) in children, based on a thorough review of medical literature and expert consensus.
The guideline outlines evaluation, initial treatment, follow-up management, and when to refer to specialists, providing a comprehensive framework for primary care providers and pediatric gastroenterologists to address GERD effectively in infants and older children.
Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children: recommendations of the North American Society for Pediatric Gastroenterology and Nutrition.Rudolph, CD., Mazur, LJ., Liptak, GS., et al.[2022]

Citations

Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. [2022]
Partial symptom-response to proton pump inhibitors in patients with non-erosive reflux disease or reflux oesophagitis - a post hoc analysis of 5796 patients. [2022]
Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children: recommendations of the North American Society for Pediatric Gastroenterology and Nutrition. [2022]
Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. [2022]
Proton Pump Inhibitor Therapy for the Treatment of Laryngopharyngeal Reflux: A Meta-Analysis of Randomized Controlled Trials. [2016]
Gastroesophageal reflux in obesity: the effect of lap-band placement. [2013]
Abnormal esophageal acid exposure is common in morbidly obese patients and improves after a successful Lap-band system implantation. [2015]
[Lifestyle modification as a medical treatment for GERD]. [2011]
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