Nausea Clinical Trial
Official title:
Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting
The aim of this clinical trial is to assess the symptomatic efficacy and the impact on the
utilization of healthcare resources of a treatment by gastric electrical stimulation
(ENTERRA ®) in patients with refractory nausea and/or vomiting leading to a nutritional
impairment. Eligible patients will be those with refractory symptoms either idiopathic,
postsurgical or due to diabetes mellitus. The duration of the study will be 28 months for
each patient.
After a run-in period of 4 months during which a prospective assessment of healthcare
resources utilization and of the severity of the symptoms will be obtained, patients will be
implanted. The follow-up period after implantation of the device will last 24 months in
every patients and will be divided in two parts: a) After the first postoperative month
during which the device will remained on the "OFF" position, the first phase of the study
will be a randomized double-blind cross-over study with 2 periods of 4 months during which
the device will be activated or not. After the 9th month of follow up, the trial will be an
open trial and the device will be activated in all patients.
During the whole trial, patients will record all types of healthcare resources utilizations
(hospitalizations, drug treatments, endoscopic procedures…) while the symptomatic efficacy
of the treatment will be assessed by standard questionnaires at the following visits
scheduled at 1, 5, 9, 12, 18, 24 months. The glycemic control will be determined at each
visit in diabetic patients. A delayed gastric emptying will not be a selection criteria but
we have planned to analyze the clinical results of the treatment in taking into account a
delayed or normal gastric emptying during the pre-implantation period. Moreover, gastric
emptying studies have been scheduled at 5, 9, 12 and 24 months to test the impact of gastric
electrical stimulation on gastric emptying.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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