An observational study in Gastrointestinal Motility, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-30.
Sponsored by University of Louisville · Observational
The purpose of this study is to evaluate the clinical usefulness of a capsule (SmartPill\~) measuring pH, pressure and temperature from within the entire GI tract to determine gastric emptying time, combined small and large bowel transit time and total transit time. In addition, the Capsule will characterize pressure patterns and provide motility indices for the antrum and duodenum. It is believed that the condition of your digestive system can have a large impact on your overall physical health. Therefore,the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the ICU. The investigators are studying ICU patients because any change in their condition can have a large impact on their recovery.
University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
Counted across the registry records on this site, refreshed daily.
ICU patients with intracranial hemorrhage
Exclusion Criteria:
ICU patients with brain injuries who will be receiving a feeding tube.
Device: SmartPill
Qualifying patients were assigned to the study within four days of hospital admission. They all received a gastro-duodenal tube and capsule. The motility capsule (SmartPill®) was placed into the capsule delivery device (AdvanCE™, US Endoscopy) and advanced blindly into the stomach and released
Transit time
The subjects were followed from the time of placement of the capsule in the stomach until the capsule was viewed in the stool or abdominal X-rays revealed it had passed from the body
Time frame: 5 days
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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University of Louisville