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New treatment option for Obesity
Official title Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
ClinicalTrials.gov ID: NCT06783751
What this study is testing
- What it's 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male and female people aged 18-65 years
- Body mass index (BMI) 35-55 kg/m2
- Must meet the BMI criteria before and after 6 months of nonsurgical weight management
- Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.
- Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery
You likely can't join if
- Hiatal hernia \>2cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or...
- Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
- Severe gastroparesis
- Previous bariatric or anti-reflux procedure
- Barrett's esophagus
- people requiring mesh treatment at time of procedure
See the full eligibility criteria
- Male and female people aged 18-65 years
- Body mass index (BMI) 35-55 kg/m2
- Must meet the BMI criteria before and after 6 months of nonsurgical weight management
- Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.
- Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery
- 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
- Must be able to provide written informed consent
- 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)
- Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
- Severe gastroparesis
- Previous bariatric or anti-reflux procedure
- Barrett's esophagus
- people requiring mesh treatment at time of procedure
- Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator
- people with pacemakers, implantable defibrillators, neurostimulators
- Portal hypertension or cirrhosis
- Chronic pancreatitis
- Active cancer treatment
- Inability to tolerate general anesthesia
- Uncontrollable coagulopathy
- Significant and uncontrolled inflammatory bowel disease
- Severe and/or uncontrolled psychiatric disorder (including psychosis, bipolar disorder) as determined during standard pre-surgery psychiatric screening at the site.
- Suicidal ideation or unstable/untreated major depressive disorder within the past year
- Alcohol or substance use disorder within the past year.
- Pregnant or breastfeeding or planning pregnancy in the coming 24 months
- Diminished intellectual capacity to consent or follow pre- and post-surgery instructions
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.