A Prospective Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator

Fluoroscopy for Spine Surgery Clinical Trial

Official title:

A Prospective, Randomized Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator Epidural Array

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02827539
• Other study ID #: Pro00070805
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: November 6, 2018

Study information

• Verified date: November 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fluoroscopy for Spine Surgery

Intervention

Device:
• LessRay
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.
• Standard Fluoroscopy
For control arm, patients will receive the standard fluoroscopy for imaging.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation exposure	Radiation dose provided to the patient in each arm of the study will be recorded	During the surgery
Primary	Efficacy as measured by image resolution	Image resolution provided by the radiation dose used in each arm of the study will be recorded.	During the surgery

External Links

•   1. Food and Drug Administration. 2010. "White Paper: Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging."
•   3. Miller SW, Castronovo FP. "Radiation Exposure and Protection in Cardiac Catheterization Laboratories." Am J Cardiology 1985; 55:171-176.