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, 2014
Last verified: October 2014

May 14, 2009
October 15, 2014
June 2009
October 2014   (final data collection date for primary outcome measure)
clinical efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00903799 on ClinicalTrials.gov Archive Site
medico-economic evaluation of ENTERRA therapy [ Time Frame: 28 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Medico-economic Evaluation of ENTERRA Therapy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Gastroparesis
  • Vomiting
  • Nausea
Device: Implantation of ENTERRA therapy
Gastric electrical stimulation using Enterra Therapy
  • 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

    Intervention: Device: Implantation of 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

    Intervention: Device: Implantation of ENTERRA therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
February 2016
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00903799
2008/046/HP
No
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Philippe DUCROTTE, Pr UH Rouen
University Hospital, Rouen
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP