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Sponsored by: |
The SmartPill Corporation |
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Information provided by: | The SmartPill Corporation |
ClinicalTrials.gov Identifier: | NCT00603707 |
Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher.
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study |
Enrollment: | 178 |
Study Start Date: | October 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Normal
healthy adult subjects with no history or current gastrointestinal disorders or conditions
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Constipated
Adult subjects with functional constipation as define by Rome II criteria
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The purpose of the study is to measure total gastrointestinal transit time using SmartPill GI Monitoring System with pH.p Capsule and compare the transit time determined by capsule transit to the conventional radioopaque marker technique.
Both techniques are simultaneously applied in normal and constipated adult populations.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
patients with constipation referred to a tertiary motility center
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Mayo Clinic, Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Kansas | |
Kansas University Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
University of Michigan Medical Center | |
Ann Arbor, Michigan, United States, 48109 | |
United States, New York | |
VA Medical Center | |
Buffalo, New York, United States, 14215 | |
United States, North Carolina | |
Wake Forest University Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Pennsylvania | |
Temple University Medical Center | |
Philadelphia, Pennsylvania, United States, 19140 |
Study Chair: | Henry Parkman, MD | Temple University Medical Center |
Responsible Party: | The SmartPill Corporation ( John R. Semler/Chief Technology Officer ) |
Study ID Numbers: | 122205 |
Study First Received: | January 8, 2008 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00603707 |
Health Authority: | United States: Institutional Review Board |
capsule constipation whole gut transit |
colonic transit gastric emptying small bowel transit |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |