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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Nationwide Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The SmartPill Corporation
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01026922
First received: December 4, 2009
Last updated: June 17, 2010
Last verified: June 2009
  Purpose

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
Gastrointestinal Motility

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The patient's tolerance using the Smartpill [ Time Frame: The day the patient returns the SmartPill recording device ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: December 2009
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
SmartPill Participants

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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients coming to clinic for concerns of gastric or small bowel dysmotility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026922

Contacts
Contact: Alex Green, DO 614-722-3363 alex.green@nationwidechildrens.org
Contact: Carlo Di Lorenzo, MD 614-722-3456 carlo.dilorenzo@nationwidechildrens.org

Locations
United States, Ohio
Center for Digestive Disorders at Nationwide Childrens Hospital Recruiting
Columbus, Ohio, United States, 43205
Sub-Investigator: Alex Green, DO         
Sponsors and Collaborators
Nationwide Children's Hospital
The SmartPill Corporation
  More Information