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 randomised 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
Effectiveness of gastric electrical stimulation in gastroparesis
(2019)
Abell et al.
Surgical treatment for refractory gastroparesis: stimulator, pyloric surgery, or both?
(2020)
Zoll et al.
Tailored approach to gastroparesis significantly improves symptoms
(2018)
Arthur et al.
Enterra Therapy supported by NICE guidelines
Gastroelectrical stimulation for gastroparesis.
Interventional procedures guidance [IPG489]
“Current evidence on the efficacy and safety of gastric electrical stimulation for gastroparesis is adequate to support the use of this procedure…”
- 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, Sarosiek I, Parkman HP, Snape W, Brody F, Wo J, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterol Motil. 2013 Oct;25(10):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.
- Gastroelectrical stimulation for gastroparesis. Interventional procedures guidance [IPG489]. www.nice.org.uk/guidance/ipg489. Published: 28 May 2014.
IMPORTANT SAFETY INFORMATION
The Enterra Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis.