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Clinical studies

French ministry of health-sponsored randomized control trial1

Objective

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.

Design

Prospective, large, multi-center, double-blinded, 1:1 randomized trial with cross-over study design across 19 centers in France.

Primary endpoint

Vomiting Score (measured 0-4 numeric scale), QOL.

Results
  • This study, the largest RCT conducted on Enterra Therapy to date, showed statistically significant improvement in symptoms at 9 months.
  • A portion of the study subjects were off-label, and the results for those patients are not presented here.
Trial-specific vomiting score

(Higher score represents improved symptoms)

ScoringFrequency of vomiting
0Several vomiting episodes a week
1No more than 1 vomiting episodes a week
2At least 1 vomiting episode a month
3Less than 1 vomiting episodes a month
4No vomiting episode
  1. 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.

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?