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Cricoid Pressure for Acid Reflux (SE-GERD Trial)
N/A
Recruiting
Led By Reza Shaker, MD
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 procedure (during simulated reflux perfusion of the esophagus)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how UES pressure can be improved to prevent pharyngeal reflux and to measure the effect of externally applied cricoid cartilage pressure on belch and swallow.
Who is the study for?
This trial is for GERD patients with regurgitation and supra-esophageal symptoms, based on American Gastroenterological Association guidelines. It's not for those under 20 or over 85, with a history of alcohol/drug abuse, certain GI/ENT/pulmonary diseases, inability to consent, pregnancy, cancer treatments history, or Lidocaine allergy.
What is being tested?
The study tests if applying pressure to the cricoid cartilage can prevent acid reflux into the throat by strengthening the upper esophageal sphincter (UES). The effect on swallowing and belching will also be observed to ensure these functions aren't negatively impacted.
What are the potential side effects?
Potential side effects may include discomfort at the site of applied pressure. Since this intervention is non-invasive and does not involve medication ingestion, severe side effects are unlikely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ procedure (during simulated reflux perfusion of the esophagus)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure (during simulated reflux perfusion of the esophagus)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Endoscopic evidence of supra-esophageal reflux
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with supra-esophageal gastroesophageal reflux diseaseExperimental Treatment1 Intervention
GERD patients with complaints of regurgitation and supra-esophageal symptoms
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,612 Total Patients Enrolled
Reza Shaker, MDPrincipal InvestigatorMedical College of Wisconsin
4 Previous Clinical Trials
629 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 20 or older than 85.I have had diseases in my upper GI, ears, nose, throat, or lungs that could affect swallowing or my stomach.I am unable to understand and give consent for treatment.I have GERD with symptoms like heartburn and throat issues.I have had cancer and received chemotherapy and radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with supra-esophageal gastroesophageal reflux disease
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.