Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT01551966
Eligibility Criteria:
Inclusion Criteria:
* patients between 7 and 18 years old
* presenting a portal hypertension and/or cirrhosis
* patients who are referred for a conventional EGD under general sedation
* patients who are not participating in other clinical studies
* written informed consent obtained from the patient and his/her legal guardians.
Exclusion Criteria:
* patients presenting a contra indication for upper endoscopy or for the ingestion of the video capsule, especially those with clinical or radiological suspicion of upper gastrointestinal strictures (esophageal surgery or eosinophile esophagitys)
* patients presenting with dysphagia or gastrointestinal tract strictures (patients with Crohn's disease, small bowel carcinoma, stenosis due to the chronic use of a NSAI medication, acute necrotizing enterocolitis or prior abdominal surgery of the gastrointestinal tract); swallowing disorders with or without impaired consciousness;
* patients under calcium channel blocking agents medication;
* patient presenting with diverticulosis (Marphan's or Ehlers Danlos's syndrome)
* patients with cardiac pacemaker or other implanted electro medical device
* patients scheduled for a magnetic resonance imaging (MRI) examination within 7 days after ingestion of the capsule (and until the capsule is evacuated)
* any other life-threatening conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT01551966
Study Brief:
Protocol Section:
NCT01551966