Medico-economic Evaluation of ENTERRA Therapy

Nausea Clinical Trial

— ENTERRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903799
• Other study ID #: 2008/046/HP
• Status: Completed
• Phase: N/A
• First received: May 14, 2009
• Last updated: May 25, 2016
• Start date: June 2009
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: November 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis
• Nausea
• Vomiting

Intervention

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

Locations

Country	Name	City	State
France	UH Besancon	Besancon
France	AP-HP Jean Verdier	Bondy
France	UH Bordeaux	Bordeaux
France	UH Clermont Ferrand	Clermont Ferrand
France	AP-HP Louis Mourier	Colombes
France	Corbeil Essones Hospital	Corbeil-Essonnes
France	UH Grenoble	Grenoble
France	UH Lille	Lille
France	UH Lyon	Lyon
France	UH Marseille	Marseille
France	UH Montpellier	Montpellier
France	UH Nancy	Nancy
France	UH Nantes	Nantes
France	UH Nice	Nice
France	UH Nimes	Nimes
France	UH Poitiers	Poitiers
France	UH Rennes	Rennes
France	UH Rouen	Rouen
France	UH Strasbourg	Strasbourg
France	UH Toulouse	Toulouse
France	UH Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical efficacy		24 months	No
Secondary	medico-economic evaluation of ENTERRA therapy		28 months	No