Clinical trial NCT02827539: A Prospective Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator
Official title: A Prospective, Randomized Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator Epidural Array
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fluoroscopy for Spine Surgery
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Radiation exposure
timeFrame: During the surgery
measure: Efficacy as measured by image resolution
timeFrame: During the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke UMC
name: Nandan Lad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: