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

NCT ID: NCT02827539

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2018-11-06

Brief 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.

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

Conditions

Fluoroscopy for Spine Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Research

If the patient is randomized to the Research Arm, the physician will begin the procedure utilizing LessRay enhanced fluoroscopic images.

Group Type: OTHER

LessRay

Intervention Type: DEVICE

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.

Control

For patients in the control arm standard fluoroscopy will be used with the C-arm set to the conventional full dose setting

Group Type: OTHER

Standard Fluoroscopy

Intervention Type: DEVICE

For control arm, patients will receive the standard fluoroscopy for imaging.

Interventions

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.

Intervention Type: DEVICE

Standard Fluoroscopy

For control arm, patients will receive the standard fluoroscopy for imaging.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nandan Lad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke UMC

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Related Links

http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm

1\. Food and Drug Administration. 2010. "White Paper: Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging."

Other Identifiers

Pro00070805

Identifier Type: -

Identifier Source: org_study_id