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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01159002
Enrollment
8
Registered
2010-07-08
Start date
2007-11-30
Completion date
2009-01-31
Last updated
2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Motility

Keywords

Endoscopy, Video Capsule, Motility, Gastrointestinal

Brief summary

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.

Interventions

DEVICESmartPill

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

Sponsors

University of Louisville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Transit time5 daysThe 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026