Status:
NOT_YET_RECRUITING
Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Crohn Disease
Functional Gastrointestinal Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare the gastro-intestinal biopotentials recorded with a homemade device using surface electrodes placed on the abdomen in healthy volunteers, Crohn's disease ...
Detailed Description
Diseases and disorders of the digestive tract affect a large proportion of the world's population. These disorders or diseases degrade patients' quality of life and are costly for healthcare systems. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for all participants:
- Person age \> 18 years
- Person has been fasting for at least 12 hours
- Person who has received full information on the organization of the research and has not objected to the use of this data.
- Person affiliated to or beneficiary of a social security plan
- Person informed about study organization and having signed the informed consent
- Inclusion Criteria for healthy volunteers :
- Person has no history of chronic gastro-intestinal disease
- Person has no acute of gastro-intestinal disease
- Inclusion Criteria for Crohn's disease patients without fibrosis :
- Person is already diagnosed with Crohn's disease
- Person has underwent during the last 6 months :
- An MRI showing no fibrosis
- A blood test for C-reactive protein and fecal calprotectine
- A questionnaire to asses the Harvey-Bradshaw Index
- Inclusion Criteria for Crohn's disease patients with fibrosis :
- Person is already diagnosed with Crohn's disease
- Person has underwent during the last 6 months :
- An MRI showing fibrosis
- A blood test for C-reactive protein and fecal calprotectine
- A questionnaire to asses the Harvey-Bradshaw Index
- Inclusion Criteria for functional gastrointestinal disorders patients :
- Person is already diagnosed with functional gastrointestinal disorders
- Person has underwent an evaluation of the Rome IV criteria
- Exclusion Criteria for all participants:
- Person having a pacemaker
- Person suffering from a sensory disorder making insensitive to pain on the skin
- Person suffering from a mental or motor disorders creating uncontroled movements
- Person being allergic to one or more component of the device
- Person being allergic to : soy, dairy food, peanuts, wheat, nuts
- Person having an history of gastro-intestinal surgery
- Person suffering from injury or erythema on the abdominal skin
- Person having a contagious potential (bacterial, fungal or viral)
- Person being in menstruation period
- Person suffering from urinary incontinence
- Minor (not emancipated)
- Person of legal age (subject to a legal protection measure)
- Adult unable to give consent
Exclusion
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06197334
Start Date
March 1 2024
End Date
September 1 2025
Last Update
January 9 2024
Active Locations (1)
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1
CHRU de Nancy - Brabois
Vandœuvre-lès-Nancy, France, 54500