SmartPill Monitoring for Assessment of GI Function in SCI

Completed

Conditions studied: SCI

In brief

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, an FDA approved device, is a wireless capsule that is ingested and transmits values for GI pH, temperature, and pressure as it travels throughout the digestive system. The SmartPill can also be used to assess CTT and TTT. In comparing values for CTT, TTT, pH, temperature, and pressure in SCI patients to healthy, able-bodied controls, the SmartPill device may provide valuable insight into the pathophysiological implications of SCI on GI function. This information may allow medical professionals to provide more effective plans of care for this population, subsequentially enhancing quality and quantity of life. The SmartPill device may also provide a less invasive alternative to assessing these variables, compared to traditional modalities.

Key facts

Study ID

NCT00856648

Run by

US Department of Veterans Affairs

People needed

40

Starts

2009-04-01

Expected to finish

2011-12-01

Last updated by the study team

2012-05-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Medical Center, Bronx — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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