Can a tweaked stomach surgery stop reflux? new trial aims to find out
NCT ID NCT06783751
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This study tests a modified version of sleeve gastrectomy, a common weight-loss surgery, to see if it can reduce or prevent acid reflux (GERD) that often occurs after the standard procedure. About 44 adults with obesity and GERD will be randomly assigned to receive either the standard or the modified surgery. Researchers will measure changes in acid exposure and pressure in the esophagus to determine if the new approach improves outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: 1. Male and female subjects aged 18-65 years 2. Body mass index (BMI) 35-55 kg/m2 3. Must meet the BMI criteria before and after 6 months of nonsurgical weight management 4. Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test. 5. Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery 6. Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry and prior to surgery 7. Must be able to provide written informed consent Exclusion Criteria: 1. Hiatal hernia \>2cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at the time of surgery) 2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator 3. Severe gastroparesis 4. Previous bariatric or anti-reflux procedure 5. Barrett's esophagus 6. Subjects requiring mesh treatment at time of procedure 7. Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator 8. Subjects with pacemakers, implantable defibrillators, neurostimulators 9. Portal hypertension or cirrhosis 10. Chronic pancreatitis 11. Active cancer treatment 12. Inability to tolerate general anesthesia 13. Uncontrollable coagulopathy 14. Significant and uncontrolled inflammatory bowel disease 15. Severe and/or uncontrolled psychiatric disorder (including psychosis, bipolar disorder) as determined during standard pre-surgery psychiatric screening at the site. 16. Suicidal ideation or unstable/untreated major depressive disorder within the past year 17. Alcohol or substance use disorder within the past year. 18. Pregnant or breastfeeding or planning pregnancy in the coming 24 months 19. Diminished intellectual capacity to consent or follow pre- and post-surgery instructions 20. History of, or any current health condition that, in the opinion of the PI, would make the subject ineligible for sleeve gastrectomy, or put the subject at risk by participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, Irvine
RECRUITINGOrange, California, 92628, United States
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University of California, San Diego
RECRUITINGSan Diego, California, 92093, United States
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