A new surgical approach to reduce GERD after weight loss surgery
Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)
This study is testing a new type of weight loss surgery to see if it can help reduce acid reflux in people who have had weight loss surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 2 sites (Orange, California and 1 other locations) |
| Trial ID | NCT06783751 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a modified vertical sleeve gastrectomy (mVSG) to determine its effectiveness in reducing gastroesophageal reflux disease (GERD) compared to conventional vertical sleeve gastrectomy (cVSG). The study will measure acid exposure time (AET) using the Bravo pH test at 6-9 months post-surgery, alongside various mechanistic assessments such as esophageal manometry and endoluminal imaging. Additionally, the impact of GERD on quality of life will be evaluated using validated rating scales. The trial aims to provide insights into both clinical and mechanistic outcomes associated with this innovative surgical technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a BMI of 35-50 kg/m2 and diagnosed with GERD.
Not a fit: Patients with significant hiatal hernias or major esophageal motility disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve GERD symptoms and quality of life for patients undergoing bariatric surgery.
How similar studies have performed: While similar surgical innovations have been explored, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Orange, California and 1 other locations
- University of California, Irvine — Orange, California, United States (Recruiting)
- University of California, San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Ninh T. Nguyen, MD — University of California, Irvine
- Study coordinator: Ninh T. Nguyen, MD
- Email: ninhn@hs.uci.edu
- Phone: 714 456 8598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.