Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 10 - 18 |
| Updated: | 7/21/2018 |
| Start Date: | December 2009 |
| End Date: | June 2011 |
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.
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.
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.
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.
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
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