A Study to Detect Upper Gastrointestinal Bleeding Using a Bleeding Sensor Pill


About this study

The objective of this study is to evaluate the feasibility of detecting blood in the stomach of a patient with suspected Upper Gastrointestinal Bleeding (UGIB).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Ability to provide informed consent.
  • Clinical suspicion of UGIB based on initial physical evaluation and intake history; e.g., prior episodes of UGI, presence of comorbid illnesses or medications associated with UGIB, laboratory data and symptom assessment, and patient is a candidate for endoscopy.

Exclusion  Criteria:

  • Based on investigator’s assessment there is a clear need for urgent endoscopy or surgery at the time of consent.
  • Known GI tract stricture.
  • History of Zenker’s diverticulum and fistulas.
  • Using a pacemaker or other implantable electrical device.
  • Dysphagia or difficulties in swallowing pills the size of the capsule.
  • History of achalasia or known esophageal dysmotility.
  • History of gastroparesis.
  • History of severe constipation (1 bowel movement per week or less).
  • Currently taking medications intended for stimulation of GI motility.
  • Patients that have had Upper GI barium study within the previous 24 hours.
  • Currently pregnant or breastfeeding, or intend to become pregnant during the investigation.
  • Presence of psychological issues preventing participation.
  • Presence of known gastric bezoar.
  • History of Crohn’s disease.
  • History of small or large bowel obstruction.
  • Suspected or previously diagnosed obstructing gastrointestinal tumor.
  • Currently participating in another clinical trial that in the opinion of the investigator would interfere with the outcomes of this study or increase risk to the subject.
  • Planned MRI investigation (MRI needed before the capsule is excreted).
  • Presence of known hiatal hernia 5 cm or greater.
  • Presence of known gastrointestinal abnormalities that could impact capsule performance.
  • Presence of other concurrent conditions or known history that in the opinion of the Investigator would compromise patient safety or study objectives

Eligibility last updated 3/4/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrew Storm, M.D.

Open for enrollment

Contact information:

Karl Akiki M.D.

(507) 284-4723


More information


Publications are currently not available

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