A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time
A Comparison Trial of SmartPill Corporation GI Monitoring System With Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time
3 other identifiers
observational
148
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2005
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 8, 2005
CompletedFirst Posted
Study publicly available on registry
August 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedMay 22, 2008
May 1, 2008
8 months
August 8, 2005
May 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 minute intervals up to 6 hours
Secondary Outcomes (3)
To demonstrate that the gastric residence time as determined by SmartPill GI Monitoring System can discriminate between healthy human subjects and patients with gastroparesis
Continuous time measure until capsule elimination
To characterize pressure patterns within the antrum and duodenum in healthy subjects and patients with documented gastroparesis
Continuous time measure until capsule elimination
To characterize total GI transit time in healthy subjects
Continuous tume measure until capsule elimination
Study Arms (2)
Normal
healthy adult subjects with no history or current gastrointestinal disorders or conditions
Gastroparesis
Subjects with documented gastroparesis
Eligibility Criteria
patients with gastroparesis referred to a tertiary motility center
You may qualify if:
- Healthy males and females between ages 18-65 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
- 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.
You may not qualify if:
- 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.
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Division of Gastroenterology and Hepatology at KUMC
Kansas City, Kansas, 66160, United States
University of Louisville Medical Center
Louisville, Kentucky, 40292, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
VA Medical Center
Buffalo, New York, 14215, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Temple University Medical Center
Philadelphia, Pennsylvania, 19140, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jack Semler, PhD
SmartPill Corporation
- PRINCIPAL INVESTIGATOR
Braden Kuo, MD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2005
First Posted
August 9, 2005
Study Start
February 1, 2005
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
May 22, 2008
Record last verified: 2008-05