NCT01026922|Completed
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Sponsor study identifier
observational
22
1 country
1
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2011
Actual (reported)Study Completion
June 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 4, 2009
Actual (reported)December 7, 2009
Actual (reported)June 2011
Actual (reported)June 2011
Actual (reported)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
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. The goal is to identify the diagnostic yield of each test and exploring how they compare in detecting motor abnormalities in the GI tract.
SmartPill use will be within 180 days of ADM
The patient's tolerance using the Smartpill
The day the patient returns the SmartPill recording device
It is a single-center study, children aged 8-17 years with severe upper GI symptoms (ie, nausea, vomiting, retching, abdominal pain) referred for antroduodenal manometry (ADM) studies underwent a wireless motility capsule (smartpill) test. The scintigraphic gastric emptying study was done when clinically indicated either at the time of the ADM or at a different time within 1 year of the wireless motility capsule test. In summary, we studied symptomatic adolescents using scintigraphic gastric emptying studies, ADM, and the wireless motility capsule test, with the goal of identifying the diagnostic yield of each test and exploring how they compare in detecting motor abnormalities in the GI tract.
Patients coming to clinic for concerns of gastric or small bowel dysmotility
Center for Digestive Disorders at Nationwide Childrens Hospital
Columbus, Ohio, 43205, United States
Kuo B, McCallum RW, Koch KL, Sitrin MD, Wo JM, Chey WD, Hasler WL, Lackner JM, Katz LA, Semler JR, Wilding GE, Parkman HP. Comparison of gastric emptying of a nondigestible capsule to a radio-labelled meal in healthy and gastroparetic subjects. Aliment Pharmacol Ther. 2008 Jan 15;27(2):186-96. doi: 10.1111/j.1365-2036.2007.03564.x. Epub 2007 Oct 28.
Cassilly D, Kantor S, Knight LC, Maurer AH, Fisher RS, Semler J, Parkman HP. Gastric emptying of a non-digestible solid: assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy. Neurogastroenterol Motil. 2008 Apr;20(4):311-9. doi: 10.1111/j.1365-2982.2007.01061.x. Epub 2008 Jan 13.
Carlo Di Lorenzo, MD
Nationwide Children's Hospital
22 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2009
First Posted
December 7, 2009
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Rao SS, Kuo B, McCallum RW, Chey WD, DiBaise JK, Hasler WL, Koch KL, Lackner JM, Miller C, Saad R, Semler JR, Sitrin MD, Wilding GE, Parkman HP. Investigation of colonic and whole-gut transit with wireless motility capsule and radiopaque markers in constipation. Clin Gastroenterol Hepatol. 2009 May;7(5):537-44. doi: 10.1016/j.cgh.2009.01.017.
Primary Completion
June 2011
Actual (reported)Study Completion
June 2011
Actual (reported)Last Updated
July 19, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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