Status:
COMPLETED
Medico-economic Evaluation of ENTERRA Therapy
Lead Sponsor:
University Hospital, Rouen
Conditions:
Gastroparesis
Vomiting
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00903799
Start Date
June 1 2009
End Date
November 1 2015
Last Update
May 26 2016
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
UH Besancon
Besançon, France, 25030
2
AP-HP Jean Verdier
Bondy, France, 93143
3
UH Bordeaux
Bordeaux, France, 33076
4
UH Clermont Ferrand
Clermont-Ferrand, France, 63000