A Prospective Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator
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|ClinicalTrials.gov Identifier: NCT02827539|
Recruitment Status : Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fluoroscopy for Spine Surgery||Device: LessRay Device: Standard Fluoroscopy||Not Applicable|
The purpose of this prospective, randomized single center study is to assess the ability of LessRay to decrease overall radiation exposure during surgical placement of a spinal stimulator. A secondary objective is to analyze the efficacy of utilizing enhanced low radiation imaging in a fluoroscopically intensive pain procedure.
The population group will be 65 patients from Duke University Medical Center and Duke Raleigh Hospital who meet the medical criteria for the surgical placement of a spinal cord stimulator epidural array. They will be divided equally into 2 arms: Research and Control and randomized by a non-surgeon on the study team. That information will be recorded and placed in a sealed envelope. On the day of surgery the envelope will be delivered to the OR and opened following "time-out". At the time the envelope is opened in the OR the patient is acknowledged to be evaluable for failure or success of LessRay during the surgical procedure if they are in the research arm. The control arm cohort will proceed with the surgery as typical without LessRay.
The data from the two groups (Research vs. Control) will be analyzed using a two tailed t-test with p<.05. The risks associated specifically with the implementation of this study are with respect to loss of confidentiality. Every effort will be made to keep the information confidential
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective, Randomized Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator Epidural Array|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
If the patient is randomized to the Research Arm, the physician will begin the procedure utilizing LessRay enhanced fluoroscopic images.
A software device has been developed that combines the benefits of reduced radiation associated with low-dose and/or pulse settings while preserving and possibly offering enhanced resolution. LessRay is a software device that is viewed on a separate monitor next to the fluro screen of the C-arm.
For patients in the control arm standard fluoroscopy will be used with the C-arm set to the conventional full dose setting
Device: Standard Fluoroscopy
For control arm, patients will receive the standard fluoroscopy for imaging.
- Radiation exposure [ Time Frame: During the surgery ]Radiation dose provided to the patient in each arm of the study will be recorded
- Efficacy as measured by image resolution [ Time Frame: During the surgery ]Image resolution provided by the radiation dose used in each arm of the study will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827539
|Contact: Promila Pagadala, PHDfirstname.lastname@example.org|
|Contact: Beth Perry, RNemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Promila Pagadala, PhD 919-681-9997 firstname.lastname@example.org|
|Contact: Allison Spell 9196814937 email@example.com|
|Sub-Investigator: Peter Grossi, MD|
|Principal Investigator:||Nandan Lad, MD, PhD||Duke UMC|