Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
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|ClinicalTrials.gov Identifier: NCT01026922|
Recruitment Status : Completed
First Posted : December 7, 2009
Last Update Posted : July 26, 2017
|Condition or disease|
|Upper Gastrointestinal Motility Disorders|
ADM is a standard procedures used in children, but it has some limitations and disadvantages. Manometry studies involve placing catheters in the nose and are often poorly tolerated by children. Also, placement of the catheter requires sedation or anesthesia, the manometry test lasts several hours and involves ingestion of a meal which many children find difficult when having a catheter in their nose. The reason we are conducting this study is because we would like to find a new, less invasive, equally informative test for understanding gastrointestinal motility.
The SmartPill GI Monitoring System uses a capsule, about the size of a large vitamin or PillCam capsule, which is swallowed and passed through the stool. While in the GI tract, the capsule measures the acidity (pH) and pressures, and these measurements are used to determine how long it takes for food to leave the stomach. Pressure and pH information are sent by the capsule to a receiver that the patient will either wear on the belt or keep within 2 feet. The receiver stores data collected about the pH, temperature, and pressure inside the GI tract. The SmartPill GI Monitoring System has already been approved by the Food and Drug Administration (FDA) for use in adults but not in children.
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
- Determine if a patient's gastric and duodenal motility is considered normal or abnormal, if their motility disorder considered as neuropathic (normal amplitude of contractions) or myopathic (low amplitude or absent contractions) based on ADM vs SmartPill [ Time Frame: SmartPill use will be within 180 days of ADM ]
- The patient's tolerance using the Smartpill [ Time Frame: The day the patient returns the SmartPill recording device ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026922
|United States, Ohio|
|Center for Digestive Disorders at Nationwide Childrens Hospital|
|Columbus, Ohio, United States, 43205|