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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01026922
Recruitment Status : Completed
First Posted : December 7, 2009
Last Update Posted : July 26, 2017
The SmartPill Corporation
Information provided by (Responsible Party):
Carlo Di Lorenzo, 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.

Condition or disease
Upper Gastrointestinal Motility Disorders

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 Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
Study Start Date : December 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

SmartPill Participants

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The patient's tolerance using the Smartpill [ Time Frame: The day the patient returns the SmartPill recording device ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients coming to clinic for concerns of gastric or small bowel dysmotility

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01026922

United States, Ohio
Center for Digestive Disorders at Nationwide Childrens Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
The SmartPill Corporation

Responsible Party: Carlo Di Lorenzo, Division Chief, Nationwide Children's Hospital Identifier: NCT01026922     History of Changes
Other Study ID Numbers: NCHSmartPill-01
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Carlo Di Lorenzo, Nationwide Children's Hospital:
antroduodenal manometry
gastric dysmotility
intestinal dysmotility