RECRUITING

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

Conditions

Obesity Bariatric Surgery Sleeve Gastrectomy Gastroesophageal Reflux Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-21

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06783751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Male and female subjects aged 18-60 years 2. Body mass index (BMI) 35-50 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	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.

Inclusion Criteria

Exclusion Criteria

1. Male and female subjects aged 18-60 years
2. Body mass index (BMI) 35-50 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

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.

Contacts and Locations

Study Contact

Ninh T. Nguyen, MD

CONTACT

714 456 8598

ninhn@hs.uci.edu

Principal Investigator

Ninh T. Nguyen, MD

PRINCIPAL_INVESTIGATOR

University of California, Irvine

Ravinder K. Mittal, MD

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

University of California, Irvine

Orange, California, 92628

United States

University of California, San Diego

San Diego, California, 92093

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Ninh T. Nguyen, MD, PRINCIPAL_INVESTIGATOR, University of California, Irvine
Ravinder K. Mittal, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-21

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2025-03-21

Study Completion Date2027-07-31

Terms related to this study

Additional Relevant MeSH Terms

Obesity
Bariatric Surgery
Sleeve Gastrectomy
Gastroesophageal Reflux Disease