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SmartPill Monitoring for Assessment of GI Function in SCI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00856648
First received: March 4, 2009
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
SCI
 Device: SmartPill ingestion and monitoring

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: SmartPill Monitoring for Assessment of GI Function in SCI

Resource links provided by NLM:

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Colonic transit time (CTT) [ Time Frame: 1-4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total transit time (TTT) [ Time Frame: 1-4 days ] [ Designated as safety issue: No ]
  • Gastric emptying time (GET) [ Time Frame: 1-10 hours ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

No Biospecimens will be collected.


Estimated Enrollment: 40
Study Start Date: April 2009
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
SCI
 Device: SmartPill ingestion and monitoring
The SmartPill device will be ingested and remotely monitored until it is excreted in a normal bowel movement.
Group 2
Able-bodied
 Device: SmartPill ingestion and monitoring
The SmartPill device will be ingested and remotely monitored until it is excreted in a normal bowel movement.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

SCI and able-bodied individuals, 18-75 years of age

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856648

Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Mark A. Korsten, MD VA Medical Center, Bronx
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00856648     History of Changes
Other Study ID Numbers: B4162C-3, KOR-09-02
Study First Received: March 4, 2009
Last Updated: May 21, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on May 23, 2013