Evaluation of Gastrointestinal Motility With SmartPill

Gastrointestinal Motility Clinical Trial

Official title:

Clinical Evaluation of SmartPill Capsule for Investigation of Total Intestinal Transit Time and Intestinal Pathology in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159002
• Other study ID #: SmartPill
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: March 28, 2017
• Start date: November 2007
• Est. completion date: January 2009

Study information

• Verified date: March 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Motility

Intervention

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

Locations

Country	Name	City	State
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 days