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

NCT02827539 | Withdrawn FDA Device

• 1 other identifier: Pro00070805
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluoroscopy for Spine Surgery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Research

OTHER

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

Device: LessRay

Control

OTHER

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

Interventions

LessRay 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.

Research

Standard Fluoroscopy DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

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

Study Officials

• Nandan Lad, MD, PhD

  Duke UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 11, 2016
• Study Start: November 1, 2018
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)