Status:
COMPLETED
SmartPill Monitoring for Assessment of GI Function in SCI
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
SCI
Eligibility:
All Genders
18-75 years
Brief Summary
The present study aims to evaluate the relationship between the level of SCI and the impairment of Colonic transit time (CTT) and Total transit time (TTT) by using the SmartPill device. The SmartPill,...
Detailed Description
Total Transit Time Total transit time (TTT) is simply the amount of time (hours) it takes for a meal to travel from the mouth, through the digestive tract and for its waste by-products to be eliminate...
Eligibility Criteria
Inclusion
- Ages 18 to 75
- Spinal cord lesion at any level at least 6 months from injury
- The patient is able to understand the treatment and is willing to comply with the prescribed regimen
- At least one or more of the following symptoms:
- Bowel program \>30 minutes
- Episodes of fecal incontinence once or more per month
Exclusion
- Inadequately managed complications related to SCI
- Evidence of bowel obstruction
- Evidence of inflammatory bowel disease
- History of cerebral palsy or cerebral apoplexy
- Multiple sclerosis
- Diabetic polyneuropathy
- Previous abdominal or perianal surgery including Hernia repair , total polyp removal (not including minor surgery as appendectomy or haemorrhoidectomy)
- Pregnant or lactating
- Evidence of spinal shock
- Mentally unstable
- Treatment with more than 5 mg prednisolon per day.
- PNS implant (sacral nerve stimulation)
- History of gastric ulcers
- Disorders of swallowing
- Suspected strictures, fistulas or physiological GI obstruction.
- GI surgery within past three months
- Severe dysphagia to food or pills
- Crohns disease or diverticulitis
- Use of implanted or portable electro-mechanical medical devices such as cardiac pacemakers or infusion pumps.
- Known intolerance to the SmartPill device
- Known food allergies to any component of the standard meal
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00856648
Start Date
April 1 2009
End Date
December 1 2011
Last Update
May 23 2012
Active Locations (1)
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1
VA Medical Center, Bronx
The Bronx, New York, United States, 10468