Medico-economic Evaluation of ENTERRA Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00903799
First received: May 14, 2009
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Gastroparesis
Vomiting
Nausea
Device: Implantation of ENTERRA therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • clinical efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • medico-economic evaluation of ENTERRA therapy [ Time Frame: 28 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: June 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1

Gastric electrical stimulation using Enterra Therapy. Device activated during 4 months then device in 'OFF' position the 4 following months.

After the cross-over period, device activated until the end of the trial

Device: Implantation of ENTERRA therapy
Gastric electrical stimulation using Enterra Therapy
2

Gastric electrical stimulation using Enterra Therapy. Device in 'OFF' position during 4 months then device activated the 4 following months.

After the cross-over period, device activated until the end of the trial

Device: Implantation of ENTERRA therapy
Gastric electrical stimulation using Enterra Therapy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

Exclusion Criteria:

  1. Patients older than 70,
  2. Patients in whom nausea and/or vomiting are related to another aetiology than that previously described.
  3. Patients with an absolute contraindication for general anaethesia and surgery
  4. Patients with a contra-indication for implantation of the device
  5. Patients with a severe psychiatric disorder
  6. Patients under guardianship or curatorship
  7. Patients with a major obesity or as severe eating disorder.
  8. Patients unable to understand French.
  9. Pregnant women or nursing mothers
  10. Lack of effective contraception
  11. Patients having undergone a pancreatic graft within the previous 6 months and being in a unstable clinical conditions at enrollment
  12. Patients with an underlying disease leading to a follow-up by MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903799

Locations
France
UH Besancon
Besancon, France, 25030
AP-HP Jean Verdier
Bondy, France, 93143
UH Bordeaux
Bordeaux, France, 33076
UH Clermont Ferrand
Clermont Ferrand, France, 63000
AP-HP Louis Mourier
Colombes, France, 92071
Corbeil Essones Hospital
Corbeil-Essonnes, France, 91106
UH Grenoble
Grenoble, France, 38043
UH Lille
Lille, France, 59000
UH Lyon
Lyon, France, 69000
UH Marseille
Marseille, France, 13000
UH Montpellier
Montpellier, France, 34000
UH Nancy
Nancy, France, 54000
UH Nantes
Nantes, France, 44000
UH Nice
Nice, France, 06202
UH Nimes
Nimes, France, 30029
UH Poitiers
Poitiers, France, 86021
UH Rennes
Rennes, France, 35033
UH Rouen
Rouen, France, 76031
UH Strasbourg
Strasbourg, France, 67091
UH Toulouse
Toulouse, France, 31075
UH Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Philippe DUCROTTE, Pr UH Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00903799     History of Changes
Other Study ID Numbers: 2008/046/HP
Study First Received: May 14, 2009
Last Updated: October 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Drug-refractory gastroparesis
diabetes mellitus induced gastroparesis
Gastric electrical stimulation
Long-term multicenter study

Additional relevant MeSH terms:
Nausea
Vomiting
Gastroparesis
Signs and Symptoms, Digestive
Signs and Symptoms
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 28, 2014