QDICOMClinical Trials for Medical Devices
Do you want to demonstrate the safety and efficacy of your medical device for post-market, regulatory or marketing purposes? Do you need to collect clinical data in order to support your application for regulatory approval?
Raylytic supports manufacturers of medical devices with automated radiographic image analysis and objective image data assessment through independent, board certified radiologists. With our unique knowledge of clinical image assessment and our extensive experience working with the medical device industry and health care providers, we can support you in many areas and through the many phases of your clinical trial efforts. Our highly accurate, validated image analysis methods are a key element of radiographic study endpoints.
Compared to manual image assessment, with its inherent variability, our method allows statistical significance to be demonstrated with a smaller patient cohort or with smaller effect sizes. This difference is a key advantage of utilizing study results in support of sales activities.
As a unique laboratory obligated to maintain strict neutrality and adherence to scientific best practices, we give your data maximum credibility for review by regulatory authorities or in the eyes of your demanding customers.
Complete case documentation including image and clinical data in MS PowerPoint format is a matter of course, as is the preparation of descriptive and exploratory biostatistics and medical writing for peer-reviewed scientific journals.
Exact Quantification of Radiographic Parameters
An exact quantification of radiographic parameters is often a key element in clinical trials and post-market studies, as it provides objective evidence of the function and safety profile of a medical device. Our FXA-Method provides an objective, operator-independent analysis of radiographic parameters, such as the assessment of bony or spinal fusion (segmental range of motion), degenerative pathologies (translation, disc height), and implant function (subsidence, center of rotation), among many other applications.
An independent scientific validation (Schulze et al. J Biomechanics 2011) showed that FXA is one of the most accurate methods available for the analysis of radiographic images and has the highest intra- and inter-observer reliability. The FXA software is approved by the FDA for general diagnostic use and applications within clinical trials (510(k), K110765).
Analysis of the Center of Rotation (CoR) and segmental Range of Motion (RoM)
Analysis of segmental translation according to Meyerding et al.
Analysis of disc height
Independent qualitative analysis
With our network of experienced, board-certified radiologists, we analyze your image data independently and, where needed, in a blinded, single- or multi-reviewer system. In one scenario, two radiologists independently review images, with a third reviewer resolving ambiguous cases.
Our radiologists have decades of experience in the assessment of degenerative changes of the spine (e.g., Pfirrmann et al. Spine 2001, Griffith et al. Spine 2007, Kellgren et al. 1963), with the assessment of implant positioning (e.g., Abul-Kasim et al. Spine 2009) or the evaluation of fractures (e.g., Genant et al. JBMR1993).
Disc degeneration according to Pfirrmann et al.
Screw positioning according to Abul-Kasim et al.
Fracture classification according to Genant et al.
More services for Clinical Trials and PMCF-Studies
Development of Radiographic- and Study Protocols
A solid and well-considered clinical and radiographic protocol is the basis for a successful study. As an experienced partner, we develop study protocols tailored to your specific needs. We support you in the selection of the appropriate measures, modalities and follow-up periods.
To ensure the consistent collection of high quality data and to improve image data, we develop guidelines and protocols for patient positioning and image acquisition together with your clinical partners.
Clinical Documentation and Quality Assurance
The FXA method allows for the semi- or fully automated assessment of many skeletal and morphometric parameters in medical imaging. These parameters include sagittal balance, range of motion, spinal instability, fracture classification, disc height, foraminal and central canal dimensions, measurement of angles, center of rotation, migration, subsidence, height of joint gaps, (the absence of) implant wear, and others. The determination of these parameters in the clinic is a time consuming,
tedious process with unavoidable inter- and intra-observer variability. Recover time for your patients by integrating the FXA method into your daily routine and supplementing your patient records automatically with a seamless, accurate and reliable history of quantitative parameters from medical imaging.
Our method has its roots in spinal surgery, but it is applicable to nearly any quantifiable, radiographic, visible parameter.
Data Management
While many studies are similar, others are very specific and entirely different. Studies that include the assessment of several indexes and adjacent levels on the spine are particularly demanding in terms of data collection and analysis.
It is good to know that our highly flexible database design and our electronic data management system can be precisely adapted to your requirements, independent of the type or format of the data.
Data Analysis and Statistics
We analyze and summarize the data utilizing descriptive statistics tailored to the study design and other requirements. During the study design phase, we support you in the determination of expected effect sizes,
the calculation of the required number of patients and the description of the utilized methods. In research studies, we utilize exploratory statistical methods to identify influential factors and correlations.
Reporting
After closing the study or at predetermined intervals, we create clear and easy to comprehend reports of the collected data and the statistical analysis in PDF format.
Our standard service includes a complete individual case history including all measurements and image data.
This report includes, where possible and reasonable, animations to
visualize changes over time or the motion analysis of any procedures involving joint replacement or restoration procedures.
In agreement with the involved departments, the clinical case documentation utilizes DICOM or PDF formats and DICOM, HL7, HTTPS or SFTP for data exchange.
Data Interpretation and Medical Writing Support for Publications
Our PhDs, engineers and radiologists welcome the opportunity to assist or take the lead in creating articles for peer-reviewed scientific journals or contributing book chapters related to our methods or on studies with our involvement.
View some of our peer-reviewed publications at PubMed here