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

Study Overview
=================
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.

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

Conditions
-----------------
Upper Gastrointestinal Motility Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SmartPill Participants<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patient's tolerance using the Smartpill | Assess the tolerability and safety of the wireless motility capsule test. | The day the patient returns the SmartPill recording device | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antroduodenal manometry, gastric dysmotility, intestinal dysmotility