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Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)

Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a changed version of sleeve weight-loss surgery can reduce GERD, when stomach acid flows back into the food pipe. It is for adults ages 18–65 who have GERD and a body mass index (BMI) of 35–55.

This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–65 years old.
  • Your BMI, a measure of weight compared with height, is 35–55.
  • Your BMI is in this range both before and after 6 months of weight care without surgery.
  • A Bravo acid test shows acid in your food pipe at least 4.9% of the time.
  • Your health insurance pays for weight-loss surgery and usual care before and after surgery.
  • If you can become pregnant, you must use birth control throughout the study and have negative pregnancy tests at study entry and before surgery.
  • You can give written consent to join the study.

Who can't join

  • You have a hiatal hernia larger than 2 cm (part of the stomach pushes through the breathing muscle), a major problem moving food down your food pipe, or Barrett’s esophagus (changes in the food pipe lining).
  • Your stomach empties very slowly, you have had weight-loss or acid reflux surgery, or you need surgical mesh during the procedure.
  • You have severe heart disease, end-stage lung disease, or an implanted pacemaker, heart shock device, or nerve stimulator.
  • You have high pressure in the veins leading to the liver, liver scarring, long-term swelling of the pancreas, or serious, uncontrolled bowel inflammation. You are receiving cancer treatment.
  • You cannot tolerate medicine that keeps you asleep during surgery, or you have a blood-clotting problem that cannot be controlled.
  • You have a severe or uncontrolled mental health condition. In the past year, you have had thoughts of suicide, unstable or untreated major depression, or an alcohol or drug use disorder.
  • You are pregnant, breastfeeding, or planning to become pregnant in the next 24 months.
  • You cannot understand consent or follow surgery instructions, or the lead study doctor believes a past or current health problem makes sleeve surgery unsuitable or study participation unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

CA