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The Story

Steven Aaron Ross
I was taught fluoroscopy during my radiology residency.  I experienced the usual learning curve with the technology particularly in how to move the image intensifier correctly in coordination with the fluoroscopic image to center over the region of interest.  Once I had learned the technique, I taught the new residents the standard technique. The standard technique is to begin imaging and then find the region of interest. This technique is also referred to as "fluoro hunting".  "Fluoro hunting" is currently standard of care and the only method to align patients in fluoroscopy. 
I entered a pediatric radiology fellowship at a large children’s hospital. Since I was dealing with pediatric patients who are even more sensitive to radiation, reducing dose became even more important. We used collimation, pulsed fluoroscopy, and technical hygiene to limit the dose. Fluoroscopy time was used as a surrogate for dose and a rating of the fellow's technique. It became a competition to see who could achieve the lowest fluoroscopy times. Fluoro-hunting frustrated our attempts to lower our dose even further. Holding down the fluoro button while centering the patient was necessary to align the patient but the fluoroscopy images received while aligning were not actually used in diagnosis. 
After my fellowship, I began working as a pediatric radiologist at a dedicated children's hospital. I continued to use careful technique to limit my fluoroscopy times. In order to restrict the amount of radiation used during alignment, I used my free hand to help guess the patient’s position as much as possible. I also trained my technologists to optimally position the patients for me. Patient movement also contributed to non-diagnostic radiation. Patients and referring clinicians often asked me about the dose, and while I used every available technique to restrict the radiation exposure, I had to admit that the fluoroscopic procedures still remained a significant contributor to overall patient dose. 
I continued to read the scientific literature hoping to find a new method or technology that would allow me to further reduce radiation exposure. Many studies were produced detailing methods and technologies that reduced radiation in radiography and computed tomography (CT). I was frustrated to see that relatively little was being done for fluoroscopy which is known to significantly contribute to both pediatric and adult dose. 
I decided to develop my own solution to the problem of non-diagnostic dose in fluoroscopy. I had been toying with using a regular optical video camera that is calibrated to the expected fluoroscopic image such that the optical camera could be employed rather than fluoroscopy to align and follow the patient. 
I further developed the idea and sought patent protection hoping it would allow faster adoption by manufacturers since it increased the potential for competitive advantage. I obtained a provisional patent. 
I then began designing the first working prototype using small optical cameras connected to a monitor.  I then calibrated the cameras to the fluoroscopy machine and placed centrality markers on the video monitor.  I attached this equipment to the existing fluoroscopy machine in use at my hospital. I designed a feasibility study to determine if the device was potentially effective at reducing dose on pediatric fluoroscopic exams.  After designing the study, I sought approval from the radiology department, hospital administration, hospital engineering, medical staff and research committee, and the institutional review board (IRB). I received approval.

I performed 20 UGIs and 20 VCUGs with the device and compared them to exams I had performed the year before without the device.  I achieved a reduction of 80.2% on VCUGs and 85.5% on UGIs.  These reductions correlate well with the literature where fluoro-hunting is estimated to account for 80% of fluoroscopic dose. 

While the primary component of this reduction is likely initial optical alignment, unintended benefits were also encountered.  The device allowed timing of fluoroscopy with patient events such as urination and ingestion. The device also allowed following a moving patient without using fluoroscopy.  Also, parents reported a greater sense of security knowing that I was able to always see the patient under the image intensifier.  The exams were also performed more quickly given the relative freedom of movement we could allow the children.  This kept them more cooperative with the exam. 
I submitted an abstract to the 2019 Society of Pediatric Radiology (SPR 2019) annual meeting and was selected as an oral scientific presenter. The audience responded very favorably. It appears that the study has inspired other researchers to pursue further investigation into the topic. 
I submitted an abstract to the 2024 Society of Pediatric Radiology Shark Tank competition.  I was selected as a finalist and asked to present in Miami.  I refined my pitch and developed a name for the device, OFF (Optics For Fluoroscopy). 
I am now seeking a partnership with a manufacturer to integrate this device into new fluoroscopy machines.  Creating a stand-alone device is also possible.  However, synergies will be seen with integration into a fluoroscopy system.  For example, if the optical imaging cameras were integrated into a fluoroscopy machine, the collimation could also be shown on the optical image monitor allowing collimation prior to fluoroscopy as well. This will further reduce radiation dose. 
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