Recruiting

Gastroesophageal Reflux Disease

Sponsor:

Mayo Clinic

Code:

NCT04411823

Conditions

Gastroesophageal Reflux

Sleeve Gastrectomy

Bariatric Surgery Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EndoFLIP measurement

Study Details

Brief summary:

Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

Conditions

Gastroesophageal Reflux

Sleeve Gastrectomy

Bariatric Surgery Complication

Study ID

NCT04411823

Start date

Feb 1, 2021

Status verified date

Mar, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Intervention arm

Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy

Interventions

EndoFLIP measurement

EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.

Primary outcome measure

  • Worsening or new-onset gastroesophageal reflux disease [ Time Frame: Baseline, 6 months, and 5 years ]

Central Contacts and Locations

Central contacts

Elizabeth Lemke

5072663317Lemke.Elizabeth@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Abi Stromme

507-538-8238DLRSTABUDAYYEHLAB@mayo.edu

Elizabeth Lemke

507-266-3317Lemke.elizabeth@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Gastroesophageal Reflux
  • Sleeve gastrectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-05.