Ensayos clínicos

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.