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BIONs, for Improved Tissue Health and Pressure Sore Prevention

NCT00262457 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-09-17

No results posted yet for this study

Summary

The purpose of this study was to determine the feasibility of an implanted electrical stimulation system incorporating BION microstimulators for long term use to prevent tissue breakdown in high risk patients.

Conditions

  • Pressure Ulcers
  • Spinal Cord Injury

Interventions

DEVICE

Implanted gluteal electrical stimulation system

Implanted electrical stimulation system incorporating BION microstimulators

Sponsors & Collaborators

Principal Investigators

  • Kath M. Bogie, PhD · VA Medical Center-Cleveland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2008-02-29
Completion
2008-02-29

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 NCT00262457 on ClinicalTrials.gov