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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
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Fluoroscopy for Spine Surgery Device: LessRay Device: Standard Fluoroscopy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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

Arm Intervention/treatment
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.
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.



Primary Outcome Measures :
  1. Radiation exposure [ Time Frame: During the surgery ]
    Radiation dose provided to the patient in each arm of the study will be recorded

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Promila Pagadala, PHD 336-684-7666 p.pagadala@duke.edu
Contact: Beth Perry, RN 919-684-0380 beth.perry@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Promila Pagadala, PhD    919-681-9997    p.pagadala@duke.edu   
Contact: Allison Spell    9196814937    allison.spell@duke.edu   
Sub-Investigator: Peter Grossi, MD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Nandan Lad, MD, PhD Duke UMC

Additional Information:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02827539     History of Changes
Other Study ID Numbers: Pro00070805
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No