Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Predicting gastroesophageal reflux after sleeve gastrectomy

Official title: Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)

Run by Mayo Clinic · NCT04411823 · Data updated 2026-11-12

This study is trying to find out what factors might lead to gastroesophageal reflux disease (GERD) in people after they have sleeve gastrectomy surgery.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorMayo Clinic
Academic / other
Locations2 sites (Orlando, Florida and 1 other locations)
StatusRecruiting
StartedFebruary 1, 2021
Main results expectedOctober 2028
Study endsOctober 2028
Registry record updatedMarch 5, 2026
Trial IDNCT04411823 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years with a BMI of 30 or greater who can consent to the procedure.

Probably not a fit

Patients with severe esophagitis, Barrett's esophagus, major motility disorders, or previous stomach surgeries may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify predictors for gastroesophageal reflux disease (GERD) following sleeve gastrectomy. Participants will undergo an upper endoscopy with the EndoFLIP device before the surgery to gather data on various parameters. A follow-up endoscopy will be conducted at six months post-surgery if clinically indicated, along with questionnaires over a five-year period to assess outcomes. The goal is to develop a predictive model for GERD after the procedure.

Why it matters

Potential benefit: If successful, this study could help identify patients at risk for GERD after sleeve gastrectomy, leading to better management and outcomes.

How similar studies have gone: Other studies have explored similar predictive models for post-surgical complications, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patients \> 18 years
* BMI 30 or greater kg/m2
* Participants can give a consent to the procedure
* Participants have no contraindications to LSG (gastric ulceration)

Exclusion Criteria:

* Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture.
* Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis)
* Patients with hiatal hernia \> 3 cm
* Patients with previous esophageal or stomach surgery

Where it's running

  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting
  • Orlando Health
    Orlando, Florida, United States
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.