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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Fluoroscopy for Spine Surgery
• Intervention / Treatment: Device: LessRay; Device: Standard Fluoroscopy

Detailed 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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Research; If the patient is randomized to the Research Arm, the physician will begin the procedure utilizing LessRay enhanced fluoroscopic images.	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.
Other: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation exposure	Radiation dose provided to the patient in each arm of the study will be recorded	During the surgery
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Nandan Lad, MD, PhD, Duke UMC

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): November 6, 2018
• Study Completion (Actual): November 6, 2018

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Pro00070805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No