A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time - Over 65 Years Old (GETOver65)

This study has been completed.
Sponsor:
Information provided by:
The SmartPill Corporation
ClinicalTrials.gov Identifier:
NCT00682877
First received: May 20, 2008
Last updated: May 22, 2008
Last verified: May 2008
  Purpose

The purpose of this study is to determine the correlation between gastric residence time of the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled meal as measured by gastric emptying scintigraphy for subjects 65 years of age and older.


Condition
Gastrointestinal Diseases
Stomach Diseases
Gastroparesis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Comparison Trial of SmartPill Corporation GI Monitoring System With Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time - In Subjects Over 65 Years of Age

Resource links provided by NLM:


Further study details as provided by The SmartPill Corporation:

Primary Outcome Measures:
  • To demonstrate the correlation between the gastric residence time as determined by SmartPill GI Monitoring System and the gastric emptying time of a radiolabeled meal in both healthy subjects and patients with documented gastroparesis. [ Time Frame: 30 minute intervals up to 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate that the gastric residence time as determined by SmartPill GI Monitoring System can discriminate between healthy human subjects and patients with gastroparesis [ Time Frame: Continuous time measure until capsule elimination ] [ Designated as safety issue: No ]
  • To characterize pressure patterns within the antrum and duodenum in healthy subjects and patients with documented gastroparesis [ Time Frame: Continuous time measure until capsule elimination ] [ Designated as safety issue: No ]
  • To characterize total GI transit time in healthy subjects [ Time Frame: Continuous time measure until capsule elimination ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: July 2007
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
healthy adult subjects with no history or current gastrointestinal disorders or conditions
Gastroparesis
Subjects with documented gastroparesis

Detailed Description:

Gastric emptying scintigraphy is considered the gold standard for evaluating gastric emptying and is widely available. Accurate characterization of gastric emptying may guide medical and surgical treatment choices. In addition, these techniques may allow for monitoring of therapeutic results for follow-up patient management.

The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation. This trial is for subjects 65 years of age and older.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with gastroparesis referred to a tertiary motility center - 65 years of age and older.

Criteria

Inclusion Criteria:

  • Inclusion Criteria For Healthy Subjects:

    • Healthy males and females between ages 65-80 years of age with no gastrointestinal disease as screened by the GI Disease Screening Questionnaire
    • Average bowel movement frequency of at least one bowel movement within 48 hours
    • Subjects with high probability for compliance and completion of the study
  • Inclusion Criteria For Subjects with Gastroparesis:

    • Abnormal gastric emptying as defined by local standards and documented by nuclear medicine scintigraphy performed within the last two years.
    • Males and females between ages 18-65 years of age.
    • Average bowel movement frequency of at least one bowel movement within 72 hours
    • Subjects with high probability for compliance and completion of the study
    • Upper endoscopy or upper GI within last 3 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.

Exclusion Criteria:

  • Exclusion Criteria For Healthy Subjects:

    • Prior GI surgery
    • Surgery within the past 3 months
    • Diverticulitis
    • Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
    • Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
    • Body mass index (BMI) > 35
    • Allergies to components of the test meal including eggs, bread, and jam.
    • Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
    • Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
  • Exclusion Criteria For Subjects with Gastroparesis:

    • History of gastric bezoar
    • Severe dysphagia to solid food and pills
    • Severe vomiting more than 1 time per day
    • Diverticulitis
    • Severe daily abdominal pain requiring medications for relief
    • Severe weight loss, greater than 10 lbs over the preceding 2 months.
    • Uncontrolled diabetes with a hemoglobin A1C greater than 10.
    • Excessively delayed gastric emptying time: more than 90% of a standard egg meal retained after 2 hours.
    • Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery.
    • Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy
    • Surgery within the past 3 months
    • Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
    • Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
    • BMI > 35
    • Allergies to components of the test meal including eggs, bread, and jam
    • Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682877

Locations
United States, Kansas
Division of Gastroenterology and Hepatology at KUMC
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
The SmartPill Corporation
Investigators
Principal Investigator: Braden Kuo, MD Massachusetts General Hospital
Study Director: John R Semler, PhD SmartPill Corporation
  More Information

No publications provided

Responsible Party: John R. Semler/Chief Technology Officer, The SmartPill Corporation
ClinicalTrials.gov Identifier: NCT00682877     History of Changes
Other Study ID Numbers: 102204a
Study First Received: May 20, 2008
Last Updated: May 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The SmartPill Corporation:
gastroparesis
Digestive
Gastrointestinal
Stomach
Motility
Non-Invasive
Capsule
GI
Device
Digestive System Diseases

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastroparesis
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014