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US control trial: idiopathic gastroparesis1

Objective

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.

Design

Prospective, multi-center, double-blinded, 1:1 randomized controlled trial with cross-over study design across 6 centers in the United States.

Primary endpoint

Weekly vomiting frequency (WVF); post crossover ON phase relative to OFF phase.

Results
  • In a study of 32 idiopathic gastroparetic patients, Enterra Therapy significantly reduced median WVF at 12 month follow-up.
  • Crossover periods showed a non-significant reduction in vomiting in the ON vs. OFF period which may have been due to the lack of washout effect of 6 weeks of stimulation that took place pre-randomization.
  • Enterra Therapy significantly reduced key secondary endpoints of Total Symptom Scores and number of days hospitalized at 12 months.
Median Weekly Vomiting Frequency (WVF)
N=20
N=18
Total symptom score – severity
N=19
Hospitalization days
N=19
  1. 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.

MKT-D-0006, Rev L

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?