SmartPill Monitoring for Assessment of GI Function in SCI

NCT00856648 | Completed

• 2 other identifiers: B4162C-3KOR-09-02
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

SCI

Outcome Measures

Primary Outcomes (1)

• Colonic transit time (CTT)

  1-4 days

Secondary Outcomes (2)

• Total transit time (TTT)

  1-4 days

• Gastric emptying time (GET)

  1-10 hours

Study Arms (2)

Group 1

SCI

Device: SmartPill ingestion and monitoring

Group 2

Able-bodied

Device: SmartPill ingestion and monitoring

Interventions

SmartPill ingestion and monitoring DEVICE

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Biospecimen

Retention: NONE RETAINED

No Biospecimens will be collected.

Study Officials

• Mark A. Korsten, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 6, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 23, 2012

Record last verified: 2012-05

Locations

US (1)