Medico-economic Evaluation of ENTERRA Therapy

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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Nausea Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases Vomiting

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Besancon, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Nausea and/or vomiting refractory to prokinetics and antiemetics fulfilling the following criteria

Due to diabetes mellitus type 1, secondary to oesogastric surgery (vagotomy, partial gastric resection) or idiopathic
Non related to other cause
Chronic (duration > 12 months)
Occurring at least weekly
Refractory to anti-emetics (chlorpromazine, ondansétron, granisétron) and/or prokinetics (domperidone, metoclopramide, erythromycin),
Leading to weight loss or significant reduction of food intake
occurring in patients without any contra-indication for the surgical implantation of the device, in particular severe cardiac or respiratory failure or haemostasis disorders,
in patients older than 18 years
with a negative pregnancy test at entry into the trial in women
Patients who signed the study consentment
Affiliation to the the welfare system

Exclusion criteria

Patients older than 70,
Patients in whom nausea and/or vomiting are related to another aetiology than that previously described.
Patients with an absolute contraindication for general anaethesia and surgery
Patients with a contra-indication for implantation of the device
Patients with a severe psychiatric disorder
Patients under guardianship or curatorship
Patients with a major obesity or as severe eating disorder.
Patients unable to understand French.
Pregnant women or nursing mothers
Lack of effective contraception
Patients having undergone a pancreatic graft within the previous 6 months and being in a unstable clinical conditions at enrollment
Patients with an underlying disease leading to a follow-up by MRI

Treatment and study plan

Implantation of ENTERRA therapy

Device

Gastric electrical stimulation using Enterra Therapy

Primary outcomes

clinical efficacy

Time frame: 24 months

Secondary outcomes

medico-economic evaluation of ENTERRA therapy

Time frame: 28 months

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting

Acronym: ENTERRA

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2015
First posted: May 18, 2009
Registry last updated: May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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