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Medico-economic Evaluation of ENTERRA Therapy

NCT00903799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2016-05-26

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Implantation of ENTERRA therapy

Gastric electrical stimulation using Enterra Therapy

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Philippe DUCROTTE, Pr · UH Rouen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-10-31
Completion
2015-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903799 on ClinicalTrials.gov