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Silent reflux risk after Weight-Loss surgery revealed

NCT ID NCT03705416

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study follows 250 obese adults who are having a weight-loss procedure—either surgery or an endoscopic stomach reduction. The goal is to see how often acid reflux (GERD) develops afterward, including silent reflux with no symptoms. By tracking symptoms and using tests, researchers hope to learn which procedures are safer for reflux-prone patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors choose the best weight-loss procedure to avoid or manage acid reflux in obese patients.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve health. Results may not apply to all patients or procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2019

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Obese patients with BMI 30 scheduled to undergo a bariatric interventions (endoscopic and surgical) at multiple academic medical centers in the United States offering both treatments.

Ages

18 to 75 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GERD Obesity

Contacts and locations

Locations

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Legacy Oregon Clinic

    Portland, Oregon, 97213, United States

  • Memorial Hermann Health System

    Houston, Texas, 77401, United States

  • Northwell Health

    New Hyde Park, New York, 11040, United States

  • Utah-Health: University of Utah

    Salt Lake City, Utah, 84132, United States

  • Weill Cornell

    New York, New York, 10021, United States

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