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

Completed

• Conditions: Upper Gastrointestinal Motility Disorders

• Registration Number: NCT01026922
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	SmartPill use will be within 180 days of ADM	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.

Secondary Outcome Measures

Name	Time	Method
The patient's tolerance using the Smartpill	The day the patient returns the SmartPill recording device	Assess the tolerability and safety of the wireless motility capsule test.

Trial Locations

Locations (1)

Center for Digestive Disorders at Nationwide Childrens Hospital; 🇺🇸 Columbus, Ohio, United States