N/A
Completed N=15
Presence or Absence of Blood in the GI Lumen
Upper GI Bleeding
Source: ClinicalTrials.gov NCT05415124 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Number of Participants With True Positive Results — 3 Participants
Summary
Bleedings in the upper digestive tract are common. Usually, laboratory and clinical parameters are considered to establish a suspicion for a bleeding in the digestive tract and to estimate urgency of the situation. If these parameters suggest the presence of a bleeding in the digestive tract, endoscopies are often performed to further investigate a patient's status. The above-mentioned laboratory and clinical parameters are sometimes not specific enough to reliably identify a bleeding in the upper digestive tract. The HemoPill acute is capsule device, that has a built in sensor that detects blood in the upper digestive tract. This information is valuable for the medical personnel and complements the information that is obtained from other laboratory or clinical tests
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With True Positive Results |
3 | — |
| PRIMARY Number of Participants With False Positive Results |
3 | — |
| PRIMARY Count of Participants With True Negative Results |
5 | — |
| PRIMARY Count of Participants With False Negative Results |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is scheduled for endoscopy due to suspicion of UGIB based on clinical and / or laboratory findings
- Signed informed consent
- Age ≥ 18 years
- Willingness and ability to participate in the study procedure
Exclusion Criteria
- Contraindications to the use of the HemoPill acute, such as:
- Known gastrointestinal obstruction, stricture, fistula, or diverticula
- Dysphagia or other swallowing disorders
- Pregnancy
- Incapacity to provide informed consent
- In patients with cardiac pacemakers and other implanted medical devices
Data sourced from ClinicalTrials.gov (NCT05415124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.