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SmartPill Monitoring for Assessment of GI Function in SCI

NCT00856648 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2012-05-23

No results posted yet for this study

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.

Conditions

  • SCI

Interventions

DEVICE

SmartPill ingestion and monitoring

The SmartPill device will be ingested and remotely monitored until it is excreted in a normal bowel movement.

Sponsors & Collaborators

Principal Investigators

  • Mark A. Korsten, MD · VA Medical Center, Bronx

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-04-30
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00856648 on ClinicalTrials.gov