Clinical Trials Directory

Trials / Completed

CompletedNCT01158989

Clinical Evaluation Gastrointestinal Motility With PillCam

Clinical Evaluation of Endoscopic Video Capsule for Investigation of Small Intestine Transit Time and Intestinal Pathology in Critically Ill Patients

Status
Completed
Phase
Study type
Observational
Enrollment
16 (actual)
Sponsor
University of Louisville · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the clinical usefulness of a video camera pill (PillCam) in assessing intestinal function in the small intestines of patients. It is believed that the condition of the subjects digestive system can have a large impact on their 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. The same device will be used in healthy subjects scheduled for elective ambulatory surgery.

Conditions

Interventions

TypeNameDescription
DEVICEPillCamWithin four days of hospital admission, qualifying critically ill patients were assigned to the study and received a gastro-jejunal tube and one PillCam video telemetry capsule (Given Imaging Ltd., Yoqneam, Israel). In each critical care patient, placement of the video capsule was coupled with the placement of the medically necessary feeding tube. A flexible endoscope was inserted into the patient's mouth, and then advanced into the esophagus, stomach, and upper small intestine. The capsule was placed into a capsule delivery device and released into the distal duodenum after it had passed beyond the sight of the scope; a wire was placed to facilitate passage of the feeding tube. An abdominal X-ray was obtained to confirm feeding tube tip placement.

Timeline

Start date
2006-05-01
Primary completion
2007-11-01
Completion
2008-06-01
First posted
2010-07-08
Last updated
2017-04-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01158989. Inclusion in this directory is not an endorsement.