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Clinical studies

Long-term 10-year outcomes study1

Objective

This study examined the long-term (>10 years) safety and efficacy of Enterra Therapy in patients with intractable nausea and vomiting.

Design

Retrospective, single-center French study examining 50 consecutive patients with refractory chronic nausea and/or vomiting lasting at least 12 months (failure of 2 prokinetics and antiemetics) implanted with gastric electrical stimulator.

Primary endpoint
  • Gastrointestinal Quality of Life Index (GIQLI) score.
  • Primary outcome was reduction in nausea and/or vomiting using a 5-point score.
  • Reduction in nausea and/or vomiting by 1 point, defined as >50% reduction in frequency.
Results
  • In a retrospective study of 50 patients, Enterra Therapy significantly improved primary endpoint of nausea and vomiting in 54% of patients by greater than 50% at 10 years.
  • Enterra Therapy significantly improved primary endpoint of Gastrointestinal QOL Index (GIQLI) score and patients reported high level of satisfaction (80%) with the therapy at 10 years.
Nausea
N=37
Vomiting
N=37
Gastrointestinal quality of life index (GIQLI) score
N=37
Median overall GIQLI patient satisfaction score
N=37
  1. 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.

MKT-D-0006, Rev M

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?