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Evaluation of Gastrointestinal Motility With SmartPill

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159002
First Posted: July 8, 2010
Last Update Posted: March 30, 2017
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.
Information provided by (Responsible Party):
Stefan Raugh, University of Louisville
  Purpose
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.

Condition Intervention
Gastrointestinal Motility Device: SmartPill

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of SmartPill Capsule for Investigation of Total Intestinal Transit Time and Intestinal Pathology in Critically Ill Patients

Further study details as provided by Stefan Raugh, University of Louisville:

Primary Outcome Measures:
  • 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


Enrollment: 8
Study Start Date: November 2007
Study Completion Date: January 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Critically ill ICU patients
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients with intracranial hemorrhage
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159002


Locations
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Stefan Rauch, MD University of Louisville
  More Information

Responsible Party: Stefan Raugh, Principal investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT01159002     History of Changes
Other Study ID Numbers: SmartPill
First Submitted: July 6, 2010
First Posted: July 8, 2010
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Stefan Raugh, University of Louisville:
Endoscopy, Video Capsule
Motility, Gastrointestinal