Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy

Running, not enrolling

Conditions studied: GERD, Obesity

In brief

GERD is common in the obese population. Bariatric procedures are the mainstay of therapy for these patients. Bariatric procedures can be surgical (Roux-en-Y gastric bypass and Vertical sleeve gastrectomy) or endoscopic (endoscopic sleeve gastroplasty). The rate of GERD after either treatment is unknown as is the rate of silent reflux. The study primary objective is to assess the incidence rate of GERD in bariatric patients that undergo either therapy.

Key facts

Study ID

NCT03705416

Run by

Johns Hopkins University

People needed

250

Starts

2019-03-30

Expected to finish

2028-03-30

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI ≥ 30 Kg/m2
• Patients scheduled to undergo a bariatric weight loss procedure (endoscopic or surgical)
• Patients older than 18 years and younger than 75 years of age at time of consent
• Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
• Patients willing and able to comply with study requirements for follow-up

You may not qualify if…

• Any patient with BMI < 30 Kg/m2
• Patients treated with intragastric balloons.
• Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
• Esophageal, gastric or duodenal malignancy
• Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
• Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
• Active fungal esophagitis
• Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
• General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
• Pregnant or planning to become pregnant during period of study participation
• Patient refuses or is unable to provide written informed consent
• Prior bariatric treatment procedure
• Prior surgical or endoscopic anti-reflux procedure

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• Northwell Health — New Hyde Park, New York, United States
• Weill Cornell — New York, New York, United States
• Legacy Oregon Clinic — Portland, Oregon, United States
• Memorial Hermann Health System — Houston, Texas, United States
• Utah-Health: University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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