Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262457
Status:
WITHDRAWN
Last Update Posted:
2013-09-17
First Post:
2005-12-02
Brief Title:
BIONs for Improved Tissue Health and Pressure Sore Prevention
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
BIONs for Improved Tissue Health and Pressure Sore Prevention
Status:
WITHDRAWN
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was found that the devices were not suitable for the application
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The overall goal of this project was to implement the use of a gluteal stimulation system incorporating BION microstimulators for pressure ulcer prevention in patients at high risk of tissue breakdown as a standard clinical practiceThe specific goal of this study is to establish the feasibility of a system incorporating BION microstimulators for long term use This will be achieved by a two phase study The initial phase of the study will employ biomechanical testing and in-vitro evaluations to address issues of safety and system design The specific tasks to be achieved in the initial phase are
Biomechanical testing to characterize the device response to traumatic loading conditions
In-vitro testing to determine the optimal configuration of the system specifically the effects of BION orientation and placement relative to the coil
A series of cadaveric studies to determine guidelines for the BION implantation procedure required to achieve optimal function of the gluteal stimulation system
The second phase of the study will be a pilot clinical trail of veterans with reduced mobility in order to establish clinical utility A two-arm crossover study of wheelchair users will be carried out A total of 10 subjects will be recruited to the study Participants will be randomly assigned to Group A or Group B All subjects will receive BION microstimulators implanted bilaterally adjacent to the motor point of the gluteus maximus Two stimulation regimes will be employed conditioning stimulation will be applied at night to increase muscle strength and fatigue resistance of the stimulated muscles while dynamic stimulation will be employed during the day in order to facilitate regular weight shifting thus varying seated posture and pressure distributions at the seating interface Subjects in Group A will start using dynamic and conditioning stimulation concurrently for 6 months following implantation They will then cease using all stimulation for a further 6 months of participation in the study Group B will not activate their stimulation systems for 6 months following implantation They will then commence using dynamic and conditioning stimulation for 6 months
All subjects will be followed for a 12 month period following implantation Tissue health assessments will be carried out at three month intervals throughout their participation in the study Progressive changes in gluteal tissue health will assessed by
1 Transcutaneous oxygen measurement to measure tissue blood flow
2 Interface pressure measurement to determine pressure distribution changes over the long-term due to muscle changes and over the short-term due to muscle contractions
3 Computerized tomography CT to measure muscle thickness The results of this study will provide the pilot data for the development of a full-scale clinical trial of the gluteal BION system
Biomechanical testing to characterize the device response to traumatic loading conditions
In-vitro testing to determine the optimal configuration of the system specifically the effects of BION orientation and placement relative to the coil
A series of cadaveric studies to determine guidelines for the BION implantation procedure required to achieve optimal function of the gluteal stimulation system
The second phase of the study will be a pilot clinical trail of veterans with reduced mobility in order to establish clinical utility A two-arm crossover study of wheelchair users will be carried out A total of 10 subjects will be recruited to the study Participants will be randomly assigned to Group A or Group B All subjects will receive BION microstimulators implanted bilaterally adjacent to the motor point of the gluteus maximus Two stimulation regimes will be employed conditioning stimulation will be applied at night to increase muscle strength and fatigue resistance of the stimulated muscles while dynamic stimulation will be employed during the day in order to facilitate regular weight shifting thus varying seated posture and pressure distributions at the seating interface Subjects in Group A will start using dynamic and conditioning stimulation concurrently for 6 months following implantation They will then cease using all stimulation for a further 6 months of participation in the study Group B will not activate their stimulation systems for 6 months following implantation They will then commence using dynamic and conditioning stimulation for 6 months
All subjects will be followed for a 12 month period following implantation Tissue health assessments will be carried out at three month intervals throughout their participation in the study Progressive changes in gluteal tissue health will assessed by
1 Transcutaneous oxygen measurement to measure tissue blood flow
2 Interface pressure measurement to determine pressure distribution changes over the long-term due to muscle changes and over the short-term due to muscle contractions
3 Computerized tomography CT to measure muscle thickness The results of this study will provide the pilot data for the development of a full-scale clinical trial of the gluteal BION system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None