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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

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 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, and 5 years for reporting.

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

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
3,298 Previous Clinical Trials
3,958,245 Total Patients Enrolled
Barham Abu Dayyeh, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
84 Total Patients Enrolled

Media Library

EndoFLIP measurement Clinical Trial Eligibility Overview. Trial Name: NCT04411823 — N/A
Acid Reflux Research Study Groups: Intervention arm
Acid Reflux Clinical Trial 2023: EndoFLIP measurement Highlights & Side Effects. Trial Name: NCT04411823 — N/A
EndoFLIP measurement 2023 Treatment Timeline for Medical Study. Trial Name: NCT04411823 — N/A
~44 spots leftby Sep 2025
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