Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
210 participants
OBSERVATIONAL
2009-03-31
2009-06-30
Brief Summary
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Detailed Description
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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 18 years of age to 80 years of age.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Constipated
Adult subjects with functional constipation as define by Rome II criteria
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Self reported bowel movement frequency of \< 2 bowel movements/week for at least 3 of the last 6 months.
3. Presenting at least one of the following symptoms as defined by Rome III criteria
* Feeling of incomplete evacuation with \> 25% of bowel movements
* Digital maneuvers with \> 25% of bowel movements
* Hard stools with \> 25% of bowel movements
* Feeling of blockage with \> 25% of bowel movements
* Straining with \> 25% of bowel movements
4. Constipation, not abdominal pain, as the predominant symptom.
5. Ability to stop laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to SP and ROM ingestion visit and during the study period.
6. Ability to stop proton pump inhibitors for seven days and Histamine2 blockers for three days prior to and the day of SmartPill ingestion.
7. No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes, electrolyte imbalance).
8. A normal colonoscopy or barium enema within 5 years for individuals over 50 years of age.
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Exclusion Criteria
2. Previous history of bezoars.
3. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
4. Any abdominal surgery within the past 3 months
5. Known or history of inflammatory bowel disease
6. History of diverticulitis, diverticular stricture, and other intestinal strictures
7. Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
8. Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
9. BMI \> 40 kg/m2
10. Allergies to components of the SmartBar (Appendix IX).
11. 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). Acceptable forms of birth control include oral contraceptives, double barrier method, and IUD cover and must be practiced from the time of enrollment until the time of release from the study.
12. Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
13. Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
14. Any contraindication to use of Fleets Enema.
15. Uncontrolled diabetes with a hemoglobin A1C greater than 10%.
16. Severe dysphagia to food or pills
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18 Years
80 Years
ALL
No
Sponsors
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The SmartPill Corporation
INDUSTRY
Responsible Party
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The SmartPill Corporation
Principal Investigators
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John R Semler, PHD
Role: STUDY_CHAIR
The SmartPill Corporation
Locations
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University of Arizona Health and Sciences Ctr Southern Arizona VA HealthCare System
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Med Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Med Center
Ann Arbor, Michigan, United States
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Buffalo VA Medical Center
Buffalo, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Wake Forest University Medical Center
Winston-Salem, North Carolina, United States
Temple University Medical Center
Philadelphia, Pennsylvania, United States
Queen Mary, University of London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Camilleri M, Thorne NK, Ringel Y, Hasler WL, Kuo B, Esfandyari T, Gupta A, Scott SM, McCallum RW, Parkman HP, Soffer E, Wilding GE, Semler JR, Rao SS. Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterol Motil. 2010 Aug;22(8):874-82, e233. doi: 10.1111/j.1365-2982.2010.01517.x. Epub 2010 May 11.
Other Identifiers
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120508
Identifier Type: -
Identifier Source: org_study_id
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