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SmartPill Monitoring for Assessment of GI Function in SCI

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ClinicalTrials.gov Identifier: NCT00856648
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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, 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 or disease Intervention/treatment
SCI Device: SmartPill ingestion and monitoring

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: SmartPill Monitoring for Assessment of GI Function in SCI
Study Start Date : April 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : December 2011

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Colonic transit time (CTT) [ Time Frame: 1-4 days ]

Secondary Outcome Measures :
  1. Total transit time (TTT) [ Time Frame: 1-4 days ]
  2. Gastric emptying time (GET) [ Time Frame: 1-10 hours ]

Biospecimen Retention:   None Retained
No Biospecimens will be collected.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856648


Locations
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United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Mark A. Korsten, MD VA Medical Center, Bronx
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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00856648    
Other Study ID Numbers: B4162C-3
KOR-09-02 ( Other Identifier: James J. Peters VA Medical Center )
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012