Evaluation of Gastrointestinal Motility With SmartPill

NCT ID: NCT01159002

Last Updated: 2017-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Motility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill ICU patients

ICU patients with brain injuries who will be receiving a feeding tube.

SmartPill

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Stefan Raugh

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Rauch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville Hospital

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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SmartPill

Identifier Type: -

Identifier Source: org_study_id

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