K92.2 K55.32
Conditions
Interventions
Group 1: To investigate the presumed advantage of rapid blood detection, the HemoPill® should be used in gastrointestinal bleeding with melena already after exclusion of active bleeding or a bleeding
Sponsors
Vivantes Klinikum im Friedrichshain Berlin Gastroenterologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Suspicion of small intestine bleeding with melena and exclusion of a bleeding source in an esophagogastroduodenoscopy 2. Written declaration of consent for participation in the study after detailed oral and written information is available 3. Age = 18 years. 4. The ability to give consent is given. 5. Compliance is expected to be given. 6. Exclusion of pregnancy.
Exclusion criteria
Exclusion criteria: 1. Lack of patient consent 2. Moribund patient 3. Pregnancy or lactation 4. Participants whose ability to consent is limited (e.g. psychiatric illnesses, language problems, no adequate education possible) 5. Age < 18 years 6. Contraindications to carrying out an examination with HemoPill® acute 7. Non-Compliance 8. Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) 9. Surgically altered anatomy of the upper GI tract (e.g. gastric resection) 10. Known or suspected gastrointestinal obstructions, strictures, fistulas or known diverticula 11. Patients with pacemakers, defibrillators or other implantable electromedical devices 12. Known allergy to parylene (capsule surface) 13. Need for a timely MRI scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are 1. the sensitivity and specificity of HemoPill® acute with regard to the detection of a bleeding source in a subsequent standard examination 2. the positive predictive value of HemoPill® acute with regard to the detection of a bleeding source in a subsequent standard examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are 1. the diagnostic yield of HemoPill® acute 2. the diagnostic yield of the device assisted enteroscopy after positive HemoPill®signal 3. the prediction of the device assisted enteroscopy direction based on the time of detection within the HemoPill® measurement 4. the successful endoscopic hemostasis, the endoscopic resection or marking of a finding worthy of surgery 5. the potential time saving up to the enteroscopic localization of the bleeding source by the sequence HemoPill® acute/ device assisted enteroscopy in the small intestine 6. the potential savings of transfusions with positive HemoPill® findings 7. the potential shortening of hospital stay with positive HemoPill® findings | — |
Countries
Germany
Contacts
Public ContactThomas Brunk
Vivantes Klinikum im Friedrichshain Berlin Gastroenterologie
Outcome results
None listed