A Prospective Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator
Withdrawn before enrolling · Not applicable
Conditions studied: Fluoroscopy for Spine Surgery
In brief
The purpose of this study is to gather information comparing LessRay Enhanced fluoroscopy with the current standard of fluoroscopy. This research is being conducted to demonstrate the utility and effectiveness of LessRay Enhanced fluoroscopy during surgical placement of a spinal cord stimulator epidural array.
Key facts
- Study ID
- NCT02827539
- Run by
- Duke University
- People needed
- 0
- Starts
- 2018-11-01
- Expected to finish
- 2018-11-06
- Last updated by the study team
- 2018-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female adults of any ethnicity
- At least 18 years-old but without an upper age limit
- Subject is willing to provide informed, written consent to participate in this study
- Subject meets the medical criteria for surgical placement of a spinal cord stimulator epidural array (e.g. not pregnant)
You may not qualify if…
- Less than 18 years of age. For both physicians involved in the study, standard of care Spinal Cord Stimulator placement is not done for those patients under 18 years of age as the literature does not show that the procedure helps in back pain of this cohort of patients
- Unable to provide informed, written consent
- Pregnant women as pregnancy makes them ineligible to undergo a surgical placement of a spinal cord stimulator
- Prior placement of a spinal cord stimulator epidural array or previous thoracic spine surgery, which could potentially make placement more difficult
- Enrollment in another study, which would prohibit participation in this study
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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