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GastroparesisENTERRANCT00903799

Medico-economic Evaluation of ENTERRA Therapy

A study testing Implantation of ENTERRA therapy in people with Gastroparesis and Vomiting, run by University Hospital, Rouen at 21 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastroparesis, Vomiting, Nausea
What is being tested?
Implantation of ENTERRA therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
21 sitesFrance
Study dates
Jun 2009to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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),
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

France21 sites

  • UH Besancon

    Besançon, 25030

  • AP-HP Jean Verdier

    Bondy, 93143

  • UH Bordeaux

    Bordeaux, 33076

  • UH Clermont Ferrand

    Clermont-Ferrand, 63000

  • AP-HP Louis Mourier

    Colombes, 92071

  • Corbeil Essones Hospital

    Corbeil-Essonnes, 91106

  • UH Grenoble

    Grenoble, 38043

  • UH Lille

    Lille, 59000

  • UH Lyon

    Lyon, 69000

  • UH Marseille

    Marseille, 13000

  • UH Montpellier

    Montpellier, 34000

  • UH Nancy

    Nancy, 54000

  • UH Nantes

    Nantes, 44000

  • UH Nice

    Nice, 06202

  • UH Nimes

    Nîmes, 30029

  • UH Poitiers

    Poitiers, 86021

  • UH Rennes

    Rennes, 35033

  • UH Rouen

    Rouen, 76031

  • UH Strasbourg

    Strasbourg, 67091

  • UH Toulouse

    Toulouse, 31075

  • UH Tours

    Tours, 37044

Other trials in France

About this study

Official title: 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.

Being tested
Implantation of ENTERRA therapy
Keywords
Drug-refractory gastroparesis, diabetes mellitus induced gastroparesis, Gastric electrical stimulation, Long-term multicenter study
Medical subject headings
Gastroparesis, Vomiting, Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantation of ENTERRA therapyDevice

    Gastric electrical stimulation using Enterra Therapy

Study groups in NCT00903799
Study groupRoleWhat they receive
1OtherGastric 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
Receives: Device: Implantation of ENTERRA therapy
2OtherGastric 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
Receives: Device: Implantation of ENTERRA therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical efficacy

    Measured: 24 months

Secondary outcomes (1)

  1. medico-economic evaluation of ENTERRA therapy

    Measured: 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionOct 2014
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00903799
Sponsor's protocol ID
2008/046/HP
Acronym
ENTERRA
Status last verified
May 2016
First submitted
14 May 2009
Last updated
26 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Gourcerol G, Coffin B, Bonaz B, Hanaire H, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi P, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Ducrotte P, Guerci B; ENTERRA Research Group. Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1857-1866.e1. doi: 10.1016/j.cgh.2020.11.011. Epub 2020 Nov 13.

    PubMed 33189854

  • Ducrotte P, Coffin B, Bonaz B, Fontaine S, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi PE, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Gourcerol G, Guerci B; ENTERRA Research Group. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. 2020 Feb;158(3):506-514.e2. doi: 10.1053/j.gastro.2019.10.018. Epub 2019 Oct 21.

    PubMed 31647902

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of ENTERRA therapy in people with Gastroparesis and Vomiting, run by University Hospital, Rouen at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical efficacy (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00903799, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.

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