Obesity > Modified Vertical Sleeve Gastrectomy (mVSG)

Modified Sleeve Gastrectomy for Acid Reflux (INNOVATE-VSG Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen By Ravinder K. Mittal, MD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Irvine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with obesity who are candidates for sleeve gastrectomy surgery and suffer from gastroesophageal reflux disease (GERD). Participants should not have had previous gastric bypass surgery.

Inclusion Criteria

I am between 18 and 60 years old.

Exclusion Criteria

I need mesh for my upcoming surgery.

I do not have severe heart or end-stage lung disease.

I have portal hypertension or cirrhosis.

I have chronic pancreatitis.

I have Barrett's esophagus.

I have a hiatal hernia larger than 2cm.

I have had weight loss or anti-reflux surgery in the past.

I do not have a severe psychiatric disorder that is uncontrolled.

I have severe stomach emptying issues.

I am currently receiving treatment for cancer.

I cannot undergo surgery with general anesthesia.

I have a bleeding disorder that cannot be controlled.

I have severe and unmanaged inflammatory bowel disease.

I have not had thoughts of suicide or untreated major depression in the last year.

I am able to understand and follow surgery instructions.

Participant Groups

The study compares a new surgical method called modified Vertical Sleeve Gastrectomy (mVSG) to the standard procedure, conventional Vertical Sleeve Gastrectomy (cVSG), to see if mVSG reduces GERD symptoms after surgery.

Group I: Modified Vertical Sleeve Gastrectomy (mVSG) Experimental Treatment 1 Intervention

modified investigational vertical sleeve gastrectomy (mVSG)

Group II: Conventional Vertical Sleeve Gastrectomy (cVSG) Active Control 1 Intervention

conventional vertical sleeve gastrectomy (cVSG)

Find A Clinic Near You

Research locations nearby Select from list below to view details:

University of California, Irvine Orange, CA

University of California, San Diego San Diego, CA

Who is running the clinical trial?

University of California, Irvine Lead Sponsor

University of California, San Diego Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Collaborator

References