Introduction to the NAVIGATE trial
Dr. Joseph Sujka, Assistant Professor of GI Surgery at the University of South Florida, discusses the importance of prioritizing treatment for nausea and vomiting in gastroparesis and shares insights into the NAVIGATE Clinical Study, including its purpose, patient population, and its potential to expand understanding of treatment options.
Joseph Sujka, MD, PhD
Associate Professor of GI Surgery
University of South Florida
Enterra Therapy is approved by the FDA under a Humanitarian Device Exemption for use in drug-refractory gastroparesis. The uses evaluated in the studies above have not been approved or cleared by the FDA and are considered investigational. These investigational uses are available only to patients enrolled by physicians participating in each study, under that study’s protocol and Institutional Review Board oversight. Enrollment does not guarantee any clinical benefit.
IMPORTANT SAFETY INFORMATION
Enterra Therapy for treatment of chronic, resistant to medication nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years: patients should always discuss potential risks and benefits of the device with their physician.
HUMANITARIAN DEVICE
Authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated. What does this mean?