Patient concerns about the invasiveness of weight loss has led to considerable interest in the minimally invasive field of endoscopic bariatric therapies. These include space-occupying intragastric balloons (IGBs) and the endoscopic sleeve gastroplasty (ESG). These stomach-targeting therapies affect appetite through non-hormonal, gastric sensorimotor influences on appetite by improving satiation and satiety.
Roux en Y gastric bypass (RYGB) is one of the most effective weight loss therapies, but due to the chronic progressive nature of obesity, nearly one third of patients will experience weight regain. As the highest-volume, non-academic TORe center in the United States, True You Weight Loss has a unique opportunity to evaluate the weight loss and safety outcomes of this procedure in the community setting.
True You is excited to launch a new Gastric Fundus Ablation plus Endoscopic Sleeve Gastroplasty for Weight Loss (ABLATE WEIGHT) study developed and led by our True You Research Team. Are you interested in ESG and contributing to evidence-based research?
As the highest-volume Endoscopic Bariatric Therapy (EBT) center in the United States, True You Weight Loss is uniquely positioned to gather observational data surrounding endoscopic weight loss procedures, including weight loss outcomes and weight maintenance, short and long-term safety, and improvement in related medical comorbidities in collaboration with our patients.
The aim of this project was to determine if ESG is a safe and effective option for patients with a BMI of 40+ who are not interested in, or eligible for, traditional bariatric therapy through a retrospective, international, multicenter chart review. This retrospective study evaluated the data of over 400 patients who underwent ESG by one of two experienced bariatric endoscopists (Dr. Christopher McGowan of True You Weight Loss and Dr. Anna Hoff of Angioskope in Sao Paulo, Brazil) between May of 2018 and March of 2022 with class III obesity (BMI 40+).
Endoscopic bariatric therapies (EBTs), including the endoscopic sleeve gastroplasty (ESG) and intragastric balloons (IGBs), represent lower-risk yet effective weight loss options for patients not interested in, or eligible for, traditional bariatric surgery. However, there is limited scientific literature addressing the factors associated with receptivity to EBTs in eligible patients.
The Spatz3 Adjustable Balloon System is the world’s first and only adjustable gastric balloon. The Spatz Balloon was approved by the FDA in October 2021, after demonstrating an 84% success rate and 15% average total body weight loss, results that far exceeded every non-adjustable balloon in non-comparative studies.
Dr. McGowan directs the Clinical Research team at True You Weight Loss, bringing nearly 20 years of clinical research expertise and the same passion and energy that he dedicates to his patients’ weight loss outcomes. Dr. McGowan completed a GI Epidemiology fellowship at the University of North Carolina at Chapel Hill, where he earned a Master of Science in Clinical Research from the prestigious Gillings School of Global Public Health. He has authored numerous first-author publications in the leading scientific journals, including: Gastroenterology; Gastrointestinal Endoscopy; Obesity Surgery; Clinical Gastroenterology and Hepatology; Hepatology; Radiology; Endoscopy. Dr. McGowan is excited to contribute to advancing the field of endoscopic weight loss through True You Weight Loss’ innovative research efforts.
Dr. Maselli has passion for endoscopic bariatric therapies (EBTs), which includes conducting research to answer pertinent questions about how we can understand, modify, and improve these therapies to achieve better outcomes for our patients. His primary interests for research are the use of EBTs for fatty liver disease and other obesity-associated comorbidities, understanding the physiologic mechanisms of EBTs, defining a patient-tailored approach to EBT options, combination EBT and anti-obesity medications, and the development of novel EBTs. Dr. Maselli's interest in clinical research began while he was a gastroenterology fellow at the Mayo Clinic where he was mentored in the research of EBT, anti-obesity medications, and gastrointestinal motor function. Dr. Maselli also completed Mayo Clinic’s postdoctoral certificate program in clinical research at the Center for Clinical and Translational Science. Dr. Maselli has published widely in both medical textbooks and medical journals and looks forward to continuing to drive the field of EBT forward with novel and cutting-edge research at True You Weight Loss.
Ashley is the Lead Clinical Research Coordinator at True You Weight Loss and earned her Bachelor of Arts in Psychology from the University of Dayton and her Master’s in Public Health from Benedictine University with certification in health education and wellness promotion as well as health management and policy. She has formerly worked as a Project Manager and Research Coordinator in the field of primary care medicine in addition to Alzheimer’s disease physical health intervention studies. Additionally, she has delivered community-based nutrition and physical activity interventions for underserved populations throughout her community. Ashley is excited to combine her passion for nutrition, weight management, and relationship building with clinical research. She is driven to conduct informative and innovative research that improves the lives of patients and contributes to best practices in medicine.
Areebah earned her Bachelor of Science from the University of Illinois-Urbana Champaign in Interdisciplinary Health Sciences, with a concentration in Health and Diversity and a minor in social work, and now serves as a clinical research coordinator at True You Weight Loss. Before joining the True You team, she worked as a Research Assistant in OBGYN research, as well as a Clinical Research Assistant in a research weight loss program that focused on sustainability and psychosocial determinants of health. Areebah is excited to be involved with bariatric and obesity medicine, and to support her team in the innovative research initiatives at True You Weight Loss!
Chase earned a Bachelor of Science in Biology at the University of North Carolina at Chapel Hill. As an undergraduate, he fell in love with clinical research while studying prenatal substance abuse and how it relates to baby brain development. He has served as a physical activity coach and health educator while assisting in studies aimed at improving care and outcomes for individuals with osteoarthritis. He has also worked as an EMT, assisted with COVID-19 outreach, and volunteered in projects to raise awareness about health disparities for underserved and low-income populations. Chase is excited to continue pursuing research that is truly impactful and will improve the well-being of patients.
The informed consent process is an essential part of the protection of research participants. Informed consent is an ongoing conversation and process to help patients decide whether or not to participate in a clinical trial, by understanding their role as a “subject of research”. The informed consent includes an explanation of the research purpose, how the research is conducted, the potential risks and benefits of participating, and the voluntary nature of participation. Documentation of informed consent is obtained by using an WCG IRB approved form that will be signed by the participant and the investigator.
Our informed consent process will include the following:
Source: FDA Gov | Informed Consent