Status:
COMPLETED
Interest of Pan Capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy
Lead Sponsor:
Hospital Avicenne
Collaborating Sponsors:
Adeprina
Conditions:
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Irritable bowel syndrome (IBS) is a chronic disease characterized by the association of abdominal pain and transit disorders. IBS affects 5 to 10% of the population. There are several forms of IBS: IB...
Eligibility Criteria
Inclusion
- Male or female: Age ≥ 18 years and ≤ 50 years
- Patients with symptoms compatible with IBS-D or IBS-M according to the treating physician.
- Indication for colonoscopy according to the physician
- Absence of prior colonoscopy
- Patient affiliated to a social security Insurance
- Signature of signed informed consent.
Exclusion
- Functional or organic disorders of swallowing.
- Dysphagia or suspicion of digestive stenosis.
- Known Zenker Diverticule.
- Major surgical history of the digestive tract (exclusion of appendectomy, cholecystectomy, surgery of hemorrhoids).
- Known illness that could explain digestive symptoms.
- Symptoms suggestive of occlusion.
- Alteration of the general state and / or dehydration.
- Chronic uncontrolled disease.
- Disorders of consciousness.
- Uncontrolled heart disease: myocardial infarction in the last 6 months, anginal disease status, NYHA grade III and above congestive heart failure, ventricular tachycardia, ventricular fibrillation, severe heart block.
- Patient with a pacemaker or other implantable electronic medical device.
- Polyethylene glycol allergy.
- Oral iron intake in the four days preceding the video capsule.
- Pregnant or lactating woman, woman of childbearing age who has not performed a pregnancy test, women and men of childbearing potential without effective contraception.
- Impossible follow up for psychological or geographical reasons.
- Patient under safeguard of justice.
- Patient under guardianship or curatorship.
- Simultaneous participation in another clinical study.
Key Trial Info
Start Date :
November 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03806959
Start Date
November 7 2018
End Date
June 30 2022
Last Update
July 31 2024
Active Locations (1)
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1
Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
Bobigny, Île-de-France Region, France, 93000