Project Description:

Ascites, a condition associated with liver cirrhosis, leads to fluid accumulation in the abdomen, causing discomfort, digestive issues, and shortness of breath. For patients with refractory ascites, recurring paracentesis procedures are necessary to drain this fluid for relief. Current practice requires patients to visit clinics or hospitals for ultrasound exams to determine whether fluid accumulation warrants a paracentesis. If ascites depth is less than three centimeters, the patient is sent home, resulting in wasted time, money, and resources. An at-home monitoring solution could address these inefficiencies, improving patient care while reducing healthcare burdens.

Our solution, SonoSteady, combines a monitoring app and a snap-on ultrasound probe attachment. This system enables non-medically trained individuals to capture accurate abdominal scans and record symptoms and weight trends, to share with physicians. The probe attachment ensures proper positioning and contact for reliable imaging, while the app tracks critical indicators such as ascites depth, weight increases, and symptoms like abdominal discomfort or shortness of breath. Together, these components allow patients to assess whether a paracentesis is needed without frequent clinic visits.

The design has been validated through testing with non-clinicians, demonstrating ease of use and reliable scan quality. This approach addresses a total addressable market of $163 billion in the U.S. accounting for all patients with cirrhosis, with a serviceable market of $16.3 billion among patients with refractory ascites. Future steps include FDA Class IIa approval and engagement with insurance providers to explore coverage opportunities, given the device’s cost-saving potential.

By empowering patients to monitor their condition remotely, SonoSteady not only alleviates the logistical and financial burdens of managing ascites but also optimizes healthcare resources. This innovative solution has the potential to transform how ascites patients manage their care, ensuring timely and efficient treatment.