Fluoroscopy for Spine SurgeryNCT02827539
A Prospective Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator
A study testing LessRay and Standard Fluoroscopy in people with Fluoroscopy for Spine Surgery, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluoroscopy for Spine Surgery
- What is being tested?
- LessRay and Standard Fluoroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 6 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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.
Read the 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
- Being tested
- LessRay, Standard Fluoroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LessRayDevice
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.
Standard FluoroscopyDevice
For control arm, patients will receive the standard fluoroscopy for imaging.
| Study group | Role | What they receive |
|---|---|---|
| Research | Other | If the patient is randomized to the Research Arm, the physician will begin the procedure utilizing LessRay enhanced fluoroscopic images. Receives: 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 Receives: Device: Standard Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure
Radiation dose provided to the patient in each arm of the study will be recorded
Measured: 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.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start1 Nov 2018
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Why it stopped: Change in resources to support study activities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluoroscopy for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nandan Lad, MD, PhD, Principal investigator, Duke UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827539
- Sponsor's protocol ID
- Pro00070805
- Status last verified
- Nov 2018
- First submitted
- 5 Jul 2016
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator Epidural Array
- ClinicalTrials.gov ID
- NCT02827539
- Acronym / sponsor ID
- Pro00070805
- Conditions
- Fluoroscopy for Spine Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in resources to support study activities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research | Other | Device: LessRayIf the patient is randomized to the Research Arm, the physician will begin the procedure utilizing LessRay enhanced fluoroscopic images. |
| Control | Other | Device: Standard FluoroscopyFor patients in the control arm standard fluoroscopy will be used with the C-arm set to the conventional full dose setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LessRayA 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. | Device | Research |
| Standard FluoroscopyFor control arm, patients will receive the standard fluoroscopy for imaging. | Device | Control |
Primary outcome
Radiation exposure
Time frame: During the surgery
Radiation dose provided to the patient in each arm of the study will be recorded
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- 1\. Food and Drug Administration. 2010. "White Paper: Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging."Link provided by the sponsor.
- 3\. Miller SW, Castronovo FP. "Radiation Exposure and Protection in Cardiac Catheterization Laboratories." Am J Cardiology 1985; 55:171-176.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nandan Lad, MD, PhD principal investigator
Duke UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LessRay and Standard Fluoroscopy in people with Fluoroscopy for Spine Surgery, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure (time frame: During the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018; AzTrials last refreshed its copy on 31 Oct 2026.