Advice
The technology
The technology
SimpliCT (NeoRad) uses a laser beam to guide needle placement during image-guided, non-vascular procedures in the interventional radiology setting, such as biopsies, drainages, nerve infiltrations and radiofrequency ablations. The manufacturer claims that visualising the needle path using a laser beam instead of fluoroscopy or CT scans reduces the radiation dose for the operator and patient.
SimpliCT is a battery-operated movable laser unit, mounted on a rail. The rail is either attached to a standard Portegra2 (MAVIG) ceiling suspension arm (which is commonly incorporated in display monitors in NHS interventional radiology suites), or mounted on a mobile floor stand with wheels. The laser unit consists of a plastic housing containing 2 lasers: a line laser for correct horizontal positioning of the device relative to the patient, and a pointing laser for puncture guidance. An angle input wheel and display panel are used to set the needle path angle.
SimpliCT is designed to simplify the current clinical practice of freehand needle placement and reduce the number of needle manipulations needed.
The target site (such as a suspected tumour or cyst) is identified using CT, hybrid positron emission tomography (PET-CT) or cone-beam CT. The entry point on the patient's skin is marked and the desired angle and depth to the target (that is, the coordinates for the needle puncture) are calculated using the software on the existing image display. The operator then manually enters these coordinates into the front panel of SimpliCT, ensuring that the line laser is calibrated to the horizontal plane of the patient. They then move the pointing laser to the entry point, mark the desired depth on the selected needle, manually centre the hub of the needle with the laser, and move the needle into the patient. A further scan of the patient is needed to confirm the correct position of the needle before the planned procedure can begin.
Innovations
SimpliCT can be used with any third‑party CT, PET‑CT and advanced 3D angiography lab-based systems (rotational C‑arm fluoroscopy or cone‑beam CT), because it is a standalone device that does not need a separate workstation, new software or to be integrated with existing imaging systems.
SimpliCT is designed to provide additional guidance for the freehand technique in image-guided, non-vascular needle placement, reaching the target site with fewer needle passes and fewer confirmatory imaging scans. SimpliCT may improve the initial accuracy of needle placement, reducing discomfort and side effects from the puncture. The manufacturer claims that using the device provides a lower radiation dose to both the operator and patient.
Current NHS pathway or current care pathway
The current clinical practice for CT- and cone‑beam CT‑guided puncture procedures is freehand placement of a straight needle using anatomical markers. An initial control image is taken and any necessary corrections to the needle position are made. This usually depends on the difficulty of the procedure and the interventional radiologist's experience. Multiple needle passes and additional scans may therefore be necessary to reach the target.
Many biopsies and drainages in the NHS are done using ultrasound guidance, and cone‑beam CT‑guided procedures are rarely used for these clinical indications.
NICE is aware of the following CE‑marked devices that appear to fulfil a similar function as SimpliCT:
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3D-LNS (amedo Smart Tracking Solutions).
Population, setting and intended user
SimpliCT is intended for use in secondary care by radiologists in the interventional radiology suite. Some device-specific training would be needed to operate the laser guidance unit, but the freehand needle placement technique is unchanged from standard practice.
The patient population is people needing straight-needle puncture procedures such as biopsies, drainages, nerve infiltration and radiofrequency ablation.
Costs
Technology costs
The list price of SimpliCT, excluding VAT, is €33,000 (£27,845, using the XE currency converter in December 2016). This includes 1 training session to operate the product.
SimpliCT has no consumables and no maintenance is needed. Calibration is limited to simple alignment with the table during each procedure, so no calibration costs are incurred.
The manufacturer cites an expected lifespan of 10 years for SimpliCT. Assuming a patient throughput of 10 puncture procedures per week, this gives an estimated cost per use of £5.35.
Costs of standard care
The addition of SimpliCT to freehand needle placement may be considered an adjunct cost to standard care. Consumables such as catheters and straight needles would have identical costs for both SimpliCT-guided punctures and standard care.
According to the National Schedule of Reference costs for 2014/15, national average unit costs are £122 for a complex CT scan and £164 for a contrast fluoroscopy, mobile or intraoperative procedure lasting 20 to 40 minutes. For the purpose of this cost comparison we have judged these imaging types, in the outpatient setting, to be closest to CT- and cone‑beam CT‑guided puncture procedures in standard care.
For ultrasound-guided biopsies and drainages, which are more common in the NHS, the national average unit cost of a comparable mobile or intraoperative ultrasound scan is £73.
These tariffs are for imaging only and do not include the costs of the puncture procedure itself, which are assumed to be identical for both SimpliCT-guided punctures and standard care.
Resource consequences
The manufacturer has confirmed that SimpliCT is not currently used in the NHS.
The main resource consequence is the capital cost of the device. The comparative evidence identified in this briefing demonstrated that the time taken to complete SimpliCT-guided procedures depends on the clinical indication. SimpliCT-guided biopsies took longer than using freehand puncture (Kroes et al. 2016a), whereas radiofrequency ablation of osteoid osteoma was quicker using SimpliCT-guided puncture (Kroes et al. 2016b). This difference was not statistically significant.
The claimed benefits of greater patient comfort and reduced radiation dose seem plausible, but these may entail considerably greater resource use and costs than standard care.