Status:
UNKNOWN
Colonic Transit Time Validation Study
Lead Sponsor:
The SmartPill Corporation
Conditions:
Constipation
Eligibility:
All Genders
18-80 years
Brief Summary
The protocol described herein is designed to provide clinical evidence of the substantial equivalence of SmartPill GI Monitoring System (SP) to the Sitzmarks (Konsyl Pharmaceuticals, Easton, MD) radio...
Detailed Description
The primary aim of this study is to assess the equivalence of SP to ROM through characterization of device agreement using SP cutoffs for colonic and whole gut transit (59hrs and 73 hrs respectively) ...
Eligibility Criteria
Inclusion
- Males and females between ages of 18-80 years of age with symptoms of chronic functional constipation for at least one year.
- Self reported bowel movement frequency of \< 2 bowel movements/week for at least 3 of the last 6 months.
- 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
- Constipation, not abdominal pain, as the predominant symptom.
- Ability to stop laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to SP and ROM ingestion visit and during the study period.
- Ability to stop proton pump inhibitors for seven days and Histamine2 blockers for three days prior to and the day of SmartPill ingestion.
- No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes, electrolyte imbalance).
- A normal colonoscopy or barium enema within 5 years for individuals over 50 years of age.
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Exclusion
- Participation in the previous SmartPill Whole gut transit Study titled "Assessment of Whole Gut Transit Time Using the SmartPill Capsule: A Multicenter Study" Protocol Number 122205
- 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 \> 40 kg/m2
- 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). 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.
- 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.
- Uncontrolled diabetes with a hemoglobin A1C greater than 10%.
- Severe dysphagia to food or pills
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Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00857363
Start Date
March 1 2009
End Date
June 1 2009
Last Update
January 15 2010
Active Locations (13)
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1
University of Arizona Health and Sciences Ctr Southern Arizona VA HealthCare System
Tucson, Arizona, United States, 85723
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
University of Kansas Med Center
Kansas City, Kansas, United States, 66160