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EndoFLIP Measurement for Sleeve Gastrectomy GERD Prediction
N/A
Recruiting
Led By Barham Abu Dayyeh, MD
Research Sponsored by Mayo Clinic
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 baseline, 6 months, and 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking for ways to predict who will get GERD after having sleeve gastrectomy surgery.
Who is the study for?
This trial is for adults over 18 with a BMI of 30 or more who can consent to the procedure and have no gastric ulcers. It's not for those with severe esophagitis, Barrett's esophagus, peptic strictures, major swallowing muscle problems, large hiatal hernias (>3 cm), or past stomach surgeries.
What is being tested?
The study is using EndoFLIP measurement to find ways to predict acid reflux disease after sleeve gastrectomy surgery. Researchers want to see if this tool can help foresee complications related to bariatric surgery.
What are the potential side effects?
EndoFLIP involves inserting a tube into the throat and stomach during an endoscopy which may cause discomfort, gagging or risk of minor bleeding but generally has minimal side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months, and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, and 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Worsening or new-onset gastroesophageal reflux disease
Secondary study objectives
Worsening dysphagia
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: Intervention armExperimental Treatment1 Intervention
Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,344 Previous Clinical Trials
3,062,203 Total Patients Enrolled
Barham Abu Dayyeh, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe esophagitis, Barrett's esophagus, or a peptic stricture.I don't have any stomach ulcers.I have had surgery on my esophagus or stomach.I have a diagnosed esophagus movement disorder.I have a hiatal hernia larger than 3 cm.I am over 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention arm
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.
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