A Study To Detect Upper Gastrointestinal Bleeding Using A Bleeding Sensor Pill
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-012662
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 – 80 years.
- Ability to give written informed consent.
- Clinical suspicion of bleeding.
Exclusion Criteria:
- Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure ‹ 100 mmHg, heart rate › 100 / min).
- Known current stenosis of the GI tract.
- The investigation subject is 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).
- Patients who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation.
- Presence of psychological issues preventing participation.
- Stomach bezoar.
- History of Crohn's disease.
- History of diverticulitis.
- History of bowel obstruction.
- Suspected gastrointestinal tumor disease.
- Planned MRI investigation (MRI needed before the capsule is excreted).
Eligibility last updated 9/28/21. 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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Andrew Storm, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available