US control trial: diabetic gastroparesis1
This trial examined the safety and efficacy of Enterra Therapy in the treatment of chronic, intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic etiology.
Clinical evidence
Designed to deliver durable relief from nausea & vomiting
A number of key clinical studies involving diabetic and idiopathic gastroparesis patients receiving Enterra™Therapy resulted in significant nausea and vomiting symptom improvements.
US control trial: idiopathic gastroparesis2
This trial examined the safety and efficacy of Enterra Therapy in the treatment of chronic, intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of idiopathic etiology.
French ministry of health-sponsored randomized control trial3
This independent study conducted by the French Ministry of Health examined efficacy of Enterra Therapy in the treatment of chronic, intractable nausea and vomiting, with or without gastroparesis.
Long-term 10-year outcomes study4
This study examined the long-term (>10 years) safety and efficacy of Enterra Therapy in patients with intractable nausea and vomiting.
Additional clinical studies
Surgical treatment for refractory gastroparesis: stimulator, pyloric surgery, or both?
(2020)
Zoll et al.
Enterra Therapy supported by practice guidelines
AGA best practices review (2021)
“Enterra Therapy does improve refractory nausea and vomiting in some patients with gastroparesis and may improve glycemic control, nutritional status, and quality of life, while reducing hospitalizations and medication use.”5
ACG guidelines (2022)
“Gastric Electric Stimulation (GES) may be considered for control of GP symptoms as a Humanitarian Use Device (HUD).”6
- McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. 2010;8(11):947-e116. doi:10.1016/j.cgh.2010.05.020.
- McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterol Motil (2013) 25, 815–e636.
- Ducrotte P, Coffin B, Bonaz B, et al. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. 2020;158(3):506-514.e2. doi:10.1053/j.gastro.2019.10.018.
- Hedjoudje A, Huet E, Leroi AM, Desprez C, Melchior C, Gourcerol G. Efficacy of gastric electrical stimulation in intractable nausea and vomiting at 10 years: A retrospective analysis of prospectively collected data. Neurogastroenterol Motil. 2020;32(11):e13949. doi:10.1111/nmo.13949.
- Lacy BE, Tack J, Gyawali CP. AGA Clinical Practice Update on Management of Medically Refractory Gastroparesis: Expert Review [published online ahead of print, 2021 Oct 29]. Clin Gastroenterol Hepatol. 2021;S1542 3565(21)01151 4. doi:10.1016/j.cgh.2021.10.038.
- Camilleri, et al. ACG Clinical Guidelines: Gastroparesis. Am J Gastroenterol. 2022 Aug 1;117(8):1197-1220. doi: 10.14309/ajg.0000000000001874.
MKT-D-0006, Rev F
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?