Rapid assessment of small bowel bleeding by HemoPill® in transit

Not Applicable

• Conditions: K92.2; K55.32; Gastrointestinal haemorrhage, unspecified

• Registration Number: DRKS00026103
• Lead Sponsor: Vivantes Klinikum im Friedrichshain Berlin Gastroenterologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoints are<br>1. the sensitivity and specificity of HemoPill® acute with regard to the detection of a bleeding source in a subsequent standard examination<br>2. the positive predictive value of HemoPill® acute with regard to the detection of a bleeding source in a subsequent standard examination

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are <br>1. the diagnostic yield of HemoPill® acute <br>2. the diagnostic yield of the device assisted enteroscopy after positive HemoPill®signal<br>3. the prediction of the device assisted enteroscopy direction based on the time of detection within the HemoPill® measurement<br>4. the successful endoscopic hemostasis, the endoscopic resection or marking of a finding worthy of surgery<br>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<br>6. the potential savings of transfusions with positive HemoPill® findings <br>7. the potential shortening of hospital stay with positive HemoPill® findings