Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
Recruiting · Orange, San Diego, California
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Men and women ages 18-65
- •BMI 35-55 kg/m2
- •Have GERD confirmed by a Bravo pH test showing acid exposure time (AET) of 4.9% or higher
- •Women who could become pregnant must use birth control and have negative pregnancy tests at study entry and before surgery
- •Must have health insurance that pays for bariatric surgery and standard care before and after surgery
🚫 You may not be able to join if…
- •Hiatal hernia larger than 2 cm
- •Major esophageal motility disorder, severe gastroparesis, or other conditions making reflux movement problems unsafe (as judged by the study doctor)
- •You had a previous bariatric or anti-reflux procedure
- •Barrett’s esophagus
- •You are pregnant or breastfeeding, or planning pregnancy in the next 24 months
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–65
- ✓Have Obesity / overweight
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure, Depression
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06783751 · Locations: California