Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children

Completed

Conditions studied: Upper Gastrointestinal Motility Disorders

In brief

This study will test a new medical device called the SmartPill GI Monitoring System, which is now used to diagnose gastric motility disorders in adults, in children. The study will compare the SmartPill capsule findings to antroduodenal manometry (ADM), which is a standard procedure currently used for the evaluation of gastric and duodenal motility in children. The ADM studies will be done for clinical purposes and only if recommended by the patient's gastroenterologist. The research portion of the study is limited to the use of SmartPill.

Key facts

Study ID

NCT01026922

Run by

Nationwide Children's Hospital

People needed

22

Starts

2009-12-01

Expected to finish

2011-06-01

Last updated by the study team

2018-07-19

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children older than 10 years of age referred to our Motility Center to receive AD manometry studies will be offered participation to the study
• The patients will have to be able to swallow the SmartPill capsule
• The patients will need to have no evidence of strictures or narrowing

You may not qualify if…

• Inability to swallow the capsule
• Patients on TPN because of inability to tolerate enteral feedings (high likelihood of not emptying the capsule from the stomach)
• Children with evidence of strictures
• Children with history of esophageal or gastric surgeries, such as TE fistula, fundoplication, or gastrojejunostomy
• Children with a history of gastric bezoars
• Allergies to components of the test meal including eggs, bread, and jam
• Patients with history of inflammatory bowel disease

Where it is running

• Center for Digestive Disorders at Nationwide Childrens Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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