Trial record 1 of 1 for:
Assessment of Whole Gut Transit Time Using the SmartPill Capsule (WholeGut)
This study has been completed.
Information provided by:
The SmartPill Corporation
First received: January 8, 2008
Last updated: August 28, 2008
Last verified: August 2008
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study
Primary Outcome Measures:
- whole gut transit time [ Time Frame: 2 days and 5 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine regional gut (gastric, small bowel, colonic) transit times [ Time Frame: continuous time measure until caspule elimination ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2008 (Final data collection date for primary outcome measure)
healthy adult subjects with no history or current gastrointestinal disorders or conditions
Adult subjects with functional constipation as define by Rome II criteria
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 (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
patients with constipation referred to a tertiary motility center
- Males and females between ages of 18-80 years of age with functional constipation that fulfills the Rome II definition of functional constipation
- Bowel movement frequency of < 3 times per week but at least once per two weeks.
- Constipation symptoms for at least 1 year duration.
- Constipation, not abdominal pain, as the primary symptom.
- Ability to stop fiber, laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to the study and during the 5 day study period.
- Ability to stop proton pump inhibitors 7 days prior to the study and H2RAs for 3 days prior to the study.
- Previous history of bezoars.
- Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
- Any abdominal surgery within the past 3 months
- Known or history of inflammatory bowel disease
- History of diverticulitis, diverticular stricture, and other intestinal strictures
- Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
- Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
- BMI > 38
- Allergies to components of the SmartBar (Appendix IX).
- Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (A urine pregnancy test will be performed on female subjects prior to capsule ingestion).
- Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
- Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
- Any contraindication to use of Fleets Enema or balloon expulsion test.
- Uncontrolled diabetes with a hemoglobin A1C greater than 10.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00603707
|Mayo Clinic, Scottsdale
|Scottsdale, Arizona, United States, 85259 |
|University of Iowa
|Iowa City, Iowa, United States, 52242 |
|Kansas University Medical Center
|Kansas City, Kansas, United States, 66160 |
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
|University of Michigan Medical Center
|Ann Arbor, Michigan, United States, 48109 |
|VA Medical Center
|Buffalo, New York, United States, 14215 |
|Wake Forest University Baptist Medical Center
|Winston-Salem, North Carolina, United States, 27157 |
|Temple University Medical Center
|Philadelphia, Pennsylvania, United States, 19140 |
The SmartPill Corporation
||Henry Parkman, MD
||Temple University Medical Center
||John R. Semler/Chief Technology Officer, The SmartPill Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 8, 2008
||August 28, 2008
||United States: Institutional Review Board
Keywords provided by The SmartPill Corporation:
whole gut transit
small bowel transit
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
Signs and Symptoms, Digestive
Signs and Symptoms