Colon Capsule Endoscopy in Children

NACompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2018

Conditions
Inflammatory Bowel Disease
Interventions
DEVICE

Colon videocapsule endoscopy (PillCam colon 2)

"This is a simple blind (blind for the lecture of the CVC record) study to evaluate the diagnostic value of the colon capsule endoscopy for the detection and the control of colon lesions, the feasibility, tolerance and safety of the CVC compared to the conventional colonoscopy under general sedation in children presented with Inflammatory Bowel Disease.~Over one week, the patient will undergo two exams (CVC and colonoscopy under general sedation). The exams will be done by two different physicians.~In order to assess the tolerance, after the completion of both exams, the patients will be asked to answer a comfort score questionnaire.~In order to assess the safety of the CVC, the patients will have a follow-up for adverse events over a 3 weeks period after completion of the CVC and only if the colon video capsule was not recovered during the conventional colonoscopy."

Trial Locations (7)

Unknown

Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux, Bordeaux

Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Bron

Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille, Lille

Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP, Paris

Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP, Paris

Service de Pédiatrie, Hôpital Sud, CHU de Rennes, Rennes

Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse, Toulouse

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT02129972 - Colon Capsule Endoscopy in Children | Biotech Hunter | Biotech Hunter