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Cricoid Pressure for Acid Reflux (SE-GERD Trial)

N/A
Recruiting
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 weeks
Treatment ~ Varies
Follow Up ~procedure (during simulated reflux perfusion of the esophagus)
This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure (during simulated reflux perfusion of the esophagus) for reporting.

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
631 Previous Clinical Trials
1,181,868 Total Patients Enrolled

Media Library

Externally Applied Cricoid Cartilage Pressure (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05695846 — N/A
Gastroesophageal Reflux Disease Research Study Groups: Patients with supra-esophageal gastroesophageal reflux disease
Gastroesophageal Reflux Disease Clinical Trial 2023: Externally Applied Cricoid Cartilage Pressure Highlights & Side Effects. Trial Name: NCT05695846 — N/A
Externally Applied Cricoid Cartilage Pressure (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695846 — N/A
~5 spots leftby Jun 2025
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