Patients for whom endoscopic observation of the depth of the small bowel is considered necessary,corresponding to any of the following: - Patient with suspected Obscure Gastrointestinal Bleeding(OGIB) - Patient with suspected overt small intestinal bleeding - Patient with suspected small intestinal diseases below
Conditions
Interventions
Insertion of XX-45 via an oral and/or anal route
Sponsors
FUJIFILM Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age::13 to 79 years old Gender::Not specified Inpatient/outpatient:Not specified
Exclusion criteria
Exclusion criteria: 1)Patients with acute abdomen 2)Patients with severe acute inflammation 3)Patients with anaphylaxis to natural rubber 4)Patients in a very bad general condition 5)Patients with suspected intestinal perforation 6)Patients having severe blood clotting defect 7)Patients with severe hepatic function disorder 8)Patients with severe respiratory diseases or circulatory diseases 9)Gravida and possibly pregnant patients 10)Patients who have participated in other clinical trials within 3 months prior to the start of this trial. 11)Patients who do not have the capacity or intention to cooperate with the trial procedures. 12)Patients who have experienced any adverse reactions through the enteroscopy. 13)Patients, the investigator (or the subinvestigator) considers, inappropriate for entry into the trial. 14)Sick or injured persons in life-threatening conditions and from whom it seems difficult to obtain written informed consent for their participation in the trial. 15)Patients with whom insertion of the endoscope has to be conducted via the stoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Whether or not the objectives of the examination were achieved - Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactKatsuya Kikuchi
FUJIFILM Corporation Endoscopy Systems Div.
Outcome results
None listed