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 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT03438695
Eligibility Criteria:
Inclusion Criteria:
* Patients with small bowel disease with an indication for a total enteroscopy, e.g.:
* Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive Video capsule endoscopy (VCE) or negative VCE in patients who have ongoing bleeding shown by overt bleeding or continued need for blood transfusions
* Abdominal pain or chronic diarrhoea with positive findings of small bowel imaging examinations
* Noncontributory ileocolonoscopy and suspicion of Crohn's disease on small-bowel cross-sectional imaging modalities or small-bowel capsule endoscopy
* Further evaluation of known Crohn's disease or therapeutic indications in Crohn's disease
* Large polyps (\>10-15mm) in the jejunum and ileum discovered by radiological examination or small-bowel capsule endoscopy in patients with Peutz-Jeghers syndrome
* Nonresponsive or refractory coeliac disease
Exclusion Criteria:
* \- Age under 18 years
* Health status American Society of Anesthesists Classification (ASA) 4
* Pregnancy
* Coagulopathy (INR≥2.0, Platelets \< 70/nl)
* Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
* Any medical contraindication to standard enteroscopy
* Presence of any intraluminal or extraluminal foreign body in the abdominal cavity
* Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)
* Known or suspected bowel obstruction or stenosis or history of bowel obstruction
* Known coagulation disorder
* Known or suspected esophageal stricture or Schatzki ring
* Known gastric or esophageal varices
* Suspected perforation of the GI tract
* Known or suspected colonic or ileocecal valve (ICV) stricture
* Inability to tolerate sedation or general anesthesia for any reason
* Inability to tolerate endotracheal intubation
* Absence of a signed informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03438695
Study Brief:
Protocol Section:
NCT03438695