Presence or Absence of Blood in the GI Lumen

Study Overview
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Brief Summary
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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

Detailed Description
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The purpose of the study was to access safety and accuracy of Hemopill and its receiver. Patients scheduled for endoscopy on the basis of suspected UGIB are generally eligible for inclusion into the trial. After patient screening, information and obtaining informed consent, a patient is enrolled into the trial. Shortly before the scheduled endoscopy is performed, the patient ingests a HemoPill acute. Endoscopy is performed as scheduled. Blood within the GI lumen is identified if present and pictures are taken. Pathologies, if found, are treated as per clinical standard. The HemoPill acute measurement regarding presence or absence of blood in the GI lumen is compared to observations made during endoscopy.

Official Title
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Presence or Absence of Blood in the GI Lumen - Correlating a HemoPill Acute Measurement With a Subsequent Endoscopic Finding

Conditions
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Upper GI Bleeding

Intervention / Treatment
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* Device: HemoPill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HemoPIll group<br>Participants who have scheduled endoscopies will be given the HemoPill acute capsule and the HemoPill Receiver will be activated (connected to the HemPill). Approximately 20 to 60 minutes after HemoPill acute capsule ingestion, the endoscopy will start. The attending physician will proceed with the endoscopic intervention in accordance with clinical practice and NYU protocols, which is a standard procedure. In the case bleeding pathologies are found, these will be endoscopically treated as per clinical standard.For later evaluation of the HemoPill acute measurement, a statistical correlation of the obtained data from the HemoPill Acute measurement with the endoscopic findings will be performed. The HemoPill acute capsule travels through and leaves the body naturally | Device: HemoPill<br>* The HemeoPill acute capsule is a small, single use, swallowable capsule with optical sensor. Blood detection by direct measurement of blood in the sensor gap, even in an unprepared digestive tract. Wireless transmission of measured values to the HemoPill Receiver. The maximum measuring time is 9 hours. The length of the capsule is 26.3 mm and the diameter is 7.0 mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of True positive results | HemoPill acute measurement positive; Endoscopy measurement positive. HemoPill acute measurement indicates presence of blood; Endoscopy identifies fresh blood or hematin in the GI lumen | 1 hour after endoscopy procedure | 
| Number of False positive results | HemoPill acute measurement positive; Endoscopy measurement negative. HemoPill acute measurement indicates presence of blood; Endoscopy does not identify fresh blood or hematin in the GI lumen. | 1 hour after endoscopy procedure | 
| Number of True negative results | HemoPill acute measurement negative; Endoscopy measurement negative. HemoPill acute measurement does not indicate presence of blood; Endoscopy does not identify fresh blood or hematin in the GI lumen in quantities > 20 mL; Minimum latency of 20 minutes achieved. | 1 hour after endoscopy procedure | 
| Number of False negative results | HemoPill acute measurement negative; Endoscopy measurement positive. HemoPill acute measurement does not indicate presence of blood in the GI lumen; Endoscopy identifies fresh blood or hematin in the GI lumen in quantities > 20 mL; minimum latency of 20 minutes achieved. | 1 hour after endoscopy procedure |