Design of a Novel Gastrostomy Button Capable of Sensing Stomach Fullness; The Representation of Sociodemographic Diversity in Clinical Trials and Research

Technical
Enteral feeding, more commonly known as tube feeding, is a common method used to deliver nutrients to patients who cannot meet their nutritional needs orally. Patients can range from infants, the elderly, ICU patients, cancer patients, people with neurological disorders, and many more, who have a functioning gastrointestinal (GI) tract but cannot meet their nutritional needs orally. A common medical device used to accomplish this is the gastrostomy button (g-button), which is a skin-level rubber device that interfaces with the stomach and can deliver food directly. One of the most prevalent risks carried by this device is aspiration, in which gastric contents are aspirated into the esophagus, causing the patient to throw up or, in more severe cases, cause the patient to inhale foreign substances into their airways, putting them at risk for pneumonia. Aspiration is typically a complication stemming from overfeeding with the g-button. There is no existing mechanism for detecting stomach fullness during enteral feeding, which can lead to overfilling, reflux, and aspiration. The main goal of my capstone project is to design a sensor capable of detecting stomach fullness during enteral feeding, thus lowering the risk of aspiration for g-button users.
Myself along with my team are working with Luminoah, a Charlottesville medical device company, to design a device capable of sensing stomach fullness. Our design will integrate with the existing g-button design while also ensuring patient safety, comfort, and ease of use. The ultimate goal is for users of varying sizes or disease types to be able to use this technology. By integrating our device into the current g-button design, we will also be able to minimize cost and increase accessibility for the user. This device will not only lower the incidence rate of aspiration and pneumonia for users, but also decrease stress associated with enteral feeding. The device also has potential to monitor other physiological parameters of the stomach, such as pH and temperature, which can help to monitor other risks associated with enteral feeding or even be used to monitor other pathologies in patients. By designing a device capable of sensing stomach fullness, we hope to improve the overall quality of life for all g-button users.
STS
Throughout history, women and minorities have long been excluded from health research and have thus received far fewer benefits from medicine. Many years of medical abuses and mistreatments have shaped a general mistrust in medicine from these communities, however new policies and regulations within the last 50 years have helped to push for the inclusion of diverse groups in clinical testing and trials. The issue remains, though, that marginalized communities still face challenges when it comes to personalized and generalizable health care and medicine that benefits both them and their own communities. The aim of my paper is to explore the representation of sociodemographic differences in clinical trials and ultimately answer why barriers still persist when it comes to accessing these trials. I also intend to address how this impacts the development of new technologies and the idea of generalizability in medicine. I will use a thorough literature review as well as a discourse analysis to investigate the current state of diversity in clinical trials, policies affecting diversity, and the public’s personal opinions on who clinical trials are designed to benefit. Using this information, I will form conclusions on why participation might be lower across certain sociodemographic groups and also answer why certain diseases still disproportionately affect these communities despite innovations in medicine. Many entities have pushed for new policies and regulations surrounding clinical trial diversity, and many researchers have actually met standards regarding diverse clinical trials. The larger issue at hand is that certain diseases are quite disproportionately represented across different sociodemographic groups, and this often does not go into consideration when recruiting participants for clinical trials. The definition of diversity not only includes race and gender, but also socioeconomic status, environmental and social factors, access to quality health care, and much more. The intersectionality between what makes an individual diverse and the benefits they receive from clinical innovations must be put into consideration in order to increase access to and quality of health care for all members of the American population.

Bachelor of Science in Biomedical Engineering

Technical Advisor: Jordan Word, Timothy Allen

STS Advisor: Karina Rider

Technical Team Members: Kyleigh Brown, Olivia Gubbay, Evan Stewart