Presence or Absence of blood in the GI lumen Correlating a HemoPill acute measurement with a subsequent endoscopic finding

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Presence or Absence of blood in the GI lumen Correlating a HemoPill acute measurement with a subsequent endoscopic finding

Brief description of study

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. For statistical validity, 43 patients are required. Considering dropouts, a recruitment goal of 50 patients is defined.

Clinical Study Identifier: s22-00387

ClinicalTrials.gov Identifier: NCT05415124

Principal Investigator: Melissa Latorre.

Other Investigators: Sam Serouya, Tamas A Gonda, Eileen Janec, Scott M Smukalla, Lauren G. Khanna, Seth A. Gross, Adam J. Goodman, Gregory B. Haber, Maysaa El Zoghbi.

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