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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
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)
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.
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.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,352 Total Patients Enrolled
Reza ShakerPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
557 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not pregnant or breastfeeding.You are at least 18 years of age.You have GERD and experience symptoms such as chronic cough, choking, or food coming back up into your throat.You have certain conditions related to your esophagus, such as acid reflux with symptoms outside of the esophagus, inflammation of the esophagus, a hiatal hernia, or muscle problems in the esophagus.
Research Study Groups:
This trial has the following groups:- Group 1: Shaker Pressure Band GERD patients with external laryngeal pressure
- Group 2: Shaker Pressure Band GERD patients without external laryngeal pressure
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.