Evaluation of Gastrointestinal Motility With SmartPill

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01159002
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Stefan Raugh, University of Louisville

July 6, 2010
July 8, 2010
March 30, 2017
November 2007
May 2008   (Final data collection date for primary outcome measure)
Transit time [ Time Frame: 5 days ]
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
Same as current
Complete list of historical versions of study NCT01159002 on Archive Site
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Evaluation of Gastrointestinal Motility With SmartPill
Clinical Evaluation of SmartPill Capsule for Investigation of Total Intestinal Transit Time and Intestinal Pathology in Critically Ill Patients
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
ICU patients with intracranial hemorrhage
Gastrointestinal Motility
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
Critically ill ICU patients
ICU patients with brain injuries who will be receiving a feeding tube.
Intervention: Device: SmartPill
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2009
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • suffered from traumatic or non-traumatic intracranial hemorrhage and were admitted to an intensive care unit (ICU) at University of Louisville Hospital
  • sedated and had tracheal intubation and mechanical ventilation
  • older than 18 years

Exclusion Criteria:

  • younger than 18 years
  • multiple injuries, especially abdominal trauma or inflammatory bowel disease
  • history of complicated abdominal surgery or unknown type of abdominal surgery
  • clinical evidence of ileus or suspected bowel obstruction
  • a pacemaker
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Stefan Raugh, University of Louisville
University of Louisville
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Principal Investigator: Stefan Rauch, MD University of Louisville
University of Louisville
March 2017