Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
- 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 ] [ Designated as safety issue: No ]
- The patient's tolerance using the Smartpill [ Time Frame: The day the patient returns the SmartPill recording device ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026922
|Contact: Alex Green, DOfirstname.lastname@example.org|
|Contact: Carlo Di Lorenzo, MDemail@example.com|
|United States, Ohio|
|Center for Digestive Disorders at Nationwide Childrens Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Sub-Investigator: Alex Green, DO|