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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
Awards & highlights

Study Summary

This trial tests a device to help with nighttime heartburn.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,233 Total Patients Enrolled
Reza ShakerPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
557 Total Patients Enrolled

Media Library

Shaker Pressure Band (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05697393 — N/A
Acid Reflux Research Study Groups: Shaker Pressure Band GERD patients with external laryngeal pressure, Shaker Pressure Band GERD patients without external laryngeal pressure
Acid Reflux Clinical Trial 2023: Shaker Pressure Band Highlights & Side Effects. Trial Name: NCT05697393 — N/A
Shaker Pressure Band (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05697393 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative open to adults aged over 25?

"This clinical trial has specific criteria for enrollment, with a minimum age of 18 and maximum of 85 years old. Additionally, there are 12 trials that cater to those under 18 and 54 targeting the elderly population."

Answered by AI

Are there openings for participants in this experiment?

"Affirmative. According to information posted on clinicaltrials.gov, this research is currently accepting participants. This trial was first launched on January 25th 2011 and its parameters have been modified as recently as January 13th 2023. 350 individuals are needed for the study at one particular site of enrollment."

Answered by AI

What is the scope of participants involved in this trial?

"Affirmative. The information available on clinicaltrials.gov states that this investigation is currently recruiting participants. Initially posted in 2011 and most recently amended in 2023, the experiment seeks to enroll 350 individuals from a single research hub."

Answered by AI

Is it possible for me to enroll in this experiment?

"This clinical trial is attempting to recruit 350 people, aged 18 and above but below 85 years old, who are currently experiencing symptoms of acid reflux. Additional eligibility criteria include the patient being diagnosed with GERD alongside extra-esophageal manifestations (e.g., chronic cough or choking), esophagitis, hiatal hernia, achalasia, diffuse esophageal spasm; as well as not breastfeeding nor pregnant at the time of enrolment."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What site did they apply to?
Medical College of Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
External UES Band (Shaker Pressure Band) and GERD
Reza Shaker, MD 2011. "External UES Band (Shaker Pressure Band) and GERD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05697393.
All > Gerd
~15 spots leftby Nov 2024
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