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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

Study 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.Check my eligibility

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.See study design

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

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

Treatment Details

Study Objectives

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

Primary outcome measures

Worsening or new-onset gastroesophageal reflux disease

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,210 Previous Clinical Trials

3,766,957 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

Frequently Asked Questions

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

What is the participant intake for this research project?

"Affirmative. Reports on clinicaltrials.gov suggest that this experiment, originally published back in February 1st 2021, is actively seeking patients to participate. Approximately 200 individuals have to be recruited from 2 distinct medical centres."

Answered by AI

Is this research initiative recruiting participants currently?

"Affirmative. According to information published on clinicaltrials.gov, the trial has been recruiting since February 1st of 2021 and was last updated on June 13th 2022. 200 patients are necessary for this study at two different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Barham K. Abu Dayyeh, M.D. 2021. "Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04411823.

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