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Case Study: How to send angiograms in DICOM format in investigator-initiated multicenter coronary stent study COMPARE 60/80 HBR

The collection of medical images often plays a vital role to analyze the efficiency of new treatment options researched in clinical studies. The safe and regulatory compliant transfer of DICOM images from the participating sites to the Corelab must be realized in a user-friendly manner. A special challenge is the typically small budgets available for investigator-initiated studies and still, a regulatory compliant way has to be found to get the medical images from A to B. The study management from the Cardio Research Department Maasstad Hospital, Rotterdam, of the COMPARE 60/80 HBR investigator initiated, multicenter, randomized clinical trial have chosen ClinFlows’ web based dicomdrop-solution to safely collect the angiograms from the 11 participating sites in the Netherlands enrolling 736 patients.

Client:

Cardio Research Department Maasstad Hospital, Rotterdam, the Netherlands supported by a grant of SMT (Sahajanand Medical Technologies Pvt. Ltd), a leading global developer and manufacturer of minimally invasive cardiovascular devices. The study is sponsored by the Research Maatschap Cardiologen Rotterdam Zuid, associated with the Maasstad Ziekenhuis Rotterdam, the Netherlands.

Project:

Investigator-initiated, multicenter, randomized controlled study, COMPARE 60/80 HBR: Comparison of the Supraflex Cruz 60 micron stent strut versus the Ultimaster Tansei 80 micron stent strut in a High Bleeding Risk PCI population.

Project Background:

In PCI patients at high bleeding risk (HBR), international guidelines recommend a shorter duration of dual antiplatelet therapy (DAPT). While this reduces the risk of bleeding, it may also increase the risk of stent thrombosis and ischemic events. The solution for PCI patients with HBR could be the use of ultrathin stent struts, as these may reduce ischemic events with a shorter duration of DAPT. COMPARE 60/80 HBR was initiated to investigate just this. From 2020 to 2023, under the leadership of Pieter Smits, M.D., Maasstad Ziekenhuis, Study Chairman and Principal Investigator, PCI use of the ultra-thin stent strut (60 µm) Supraflex Cruz will be compared with use of the thin strut (80 µm) Ultimaster Tansei among 736 patients with HBR. The study results may open new treatment options for PCI patients with HBR. Patients are followed for 12 months.

Challenge:

All angiograms of the index procedures, or any planned staged or unplanned procedures have to be sent to the Cardio Research Department in Rotterdam by the 11 participating sites. CERC Europe, Paris, France, will perform the analysis of the angiograms. The challenge was to find a very cost-effective and easy-to-use DICOM transfer tool, which provides an automated pseudonymization of DICOM tags and meets all GDPR requirements. 

Solution:

For the safe transfer of the DICOM images, the Cardio research team of Maasstad Hospital has chosen ClinFlows’ web-based solution dicomdrop since the start of the COMPARE 60/80 HBR study. With just a few clicks, the eleven participating sites can use the platform to send their angiograms in DICOM format to Rotterdam in a very uncomplicated, fast, and GDPR-compliant way thanks to the integrated pseudonymization options. The application allows the coordinator to create a project within dicomdrop and to invite the participating sites to join the project. The sites can enter a case reference which is automatically inserted in the uploaded DICOM tags, to assure clear subject identification. The coordination team in Rotterdam receives a download link to collect the data, which are only stored on ClinFlows high-end, high-security servers in Europe. All uploaded data are automatically deleted from the dicomdrop-servers after ten days to minimize the risk and assure a high-end data privacy protection. All the sites have to do is to register on dicomdrop once in order to upload DICOMs within the Compare 60/80 HBR project.

Result:

From 2020 until today, more than 700 patients have already been recruited in this study and around 800 angiographies have already been transferred via dicomdrop. 

Client feedback:

“For the success of our study, it is crucial to have a reliable and stable technology for online image transmission. Furthermore, the whole process has to be simple, fast and secure. dicomdrop fulfills exactly these points. We are happy to have relied on this tool from the very beginning of the study and thus to gain new insights for PCI patients with HBR as quickly as possible,” says Ria van Vliet, Project Manager at Cardio Research Department, Maasstad Ziekenhuis.

Want to learn more about how our clients benefit from our solutions in practice? Simply get in touch via info(at)clinflows.com or find out here, how a leading TAVI manufacturer manages case reviews and eligibility checks to serve clients and here, how to provide clinical decision support during post-training phase.

Image source: Freepik.com / pressefoto

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Case Study clinical decision support decidemedical GDPR

Case study: How to provide clinical decision support during post-training phase

They are essential to our health: new medical products. Every year, medical device manufacturers, biotech companies, and pharmaceutical companies spend billions to develop them – and then millions to train and educate physicians to know how to use them and how to best help patients. But what happens after that, and how can medical product manufacturers support physicians when it comes to treating real people?

Once a medical product or treatment has been developed, various methods are initially used in the training phase. These range from descriptions and instructions supported by e-learning platforms, videos and audio files to sophisticated training centers with hands-on learning in real operating room facilities with training on animals or cadaver explants. Simulation software and 3D-printed artificial materials to mimic real-world scenarios are also emerging technologies for training and preparing physicians to use new treatments.

Time gap between training and first patient treatment

All of these efforts are designed to prepare medical teams for the moment when a real patient is to be treated. Right after training, what usually happens first is…. nothing! That’s because often the first treatment of a real patient doesn’t happen until weeks or months after training. This is the moment when training and reality meet. 

Now it’s up to the physician in his or her clinic to decide whether the patient meets the criteria for a particular implant or interventional treatment. The physician may need to select the right size implant or decide on the access route. 

Assessment of medical images vital during post-training-phase

Medical images play a key role in the best treatment outcome, such as methodological selection and determining the size of an implant. And this is where medical device manufacturers can come in: Namely, by supporting physicians with a second opinion at these critical moments. But this is not always so easy and, above all, often too slow, for example because of a physical distance. It is not uncommon, for example, for the attending physician and his patient to be located in Europe, but the manufacturer in the USA, and for medical images to be exchanged by mail.

Clinical decision support via web-based tools to ensure the best treatment possible

A straightforward and secure solution here can be provided by web-based clinical decision support tools, such as our GDPR-compliant online solution decidemedical, which has been used by the medical device industry for ten years. With its help, clinicians can upload their clinical data and medical images and submit them securely and compliantly to industry experts to either get their opinion on the suitability of a case or industry provides sizing services. Clinical experts from the manufacturer review and measure the medical images using specialized imaging software and submit their assessments to the physician via the web-based platform to recommend the best treatment option and implant size.

The benefits to the physician, the industry – and most importantly, the patient – from using web-based Clinical Decision Support tools in the post training phase are clear:

  • Utilization of existing medical expertise,
  • available worldwide,
  • fast turnaround time,
  • enables a controlled product launch,
  • efficient customer support,
  • compliance with regulations, and it’s
  • accessible from anywhere – no software required.

How do you manage physician support in the post-training phase? And how does your clinical team share medical images with the different sites?

Discuss here or contact us at info(at)clinflows.com

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Case Study Clients decidemedical

Case study: How a leading TAVI manufacturer manages case reviews and eligibility checks to serve clients

When launching innovative medical treatments, reviewing cases, and doing eligibility checks is of vital importance. Implanting physicians, who are located all over the world, benefit from the expertise and the support of the clinical specialists of the medical device company when treating their patients. This case study shows how communication via our clinical software decidemedical can simplify the associated complex processes for everyone involved in an easy, efficient, and regulatory-compliant manner. Skilled people combined with smart tools result in safety and excellent benefits for the patients!

Client:

One of the worldwide leading TAVI (Trans Aortic Valve Implantation) manufacturers 

Challenge:

The heart valve manufacturer, which has a highly skilled support team in the Netherlands and California, offers GDPR-compliant, fast, and easy clinical decision sizing- and support-services to its physicians which are located all over the world. Clinical information and medical images (CTs, Echos, Angios) have to be exchanged in a GDPR compliant manner. 

Solution:

On its web-based platform decidemedical, ClinFlows sets up individualized workflows based on the client’s requirements. With secured access, participating sites, from all around the world, can upload clinical data and medical images such as echos, CT’s, and angios of their potential TAVI patients. Defined DICOM tags, included in the medical images are automatically anonymized resulting in a pseudonymized data set. As soon as physicians upload a new case, the TAVI-support team is notified. The team members can directly download the clinical data and medical images, process and analyse them and send their final report as well as recommendations to the treating physician via decidemedical. The physician, in turn, is notified by email that the case has been reviewed and can consider the expert’s measurements and recommendations when treating the patient.

Workflow in practice (based on decidemedical real audit trail data):

10:11am: In the morning, a physician from Czech Republic logs in to ClinFlows’ decidemedical platform via his web-browser. The physician creates a case, enters clinical information, and uploads CT data. The individual DICOM tags included in the CT images are automatically anonymized resulting in a pseudonymized, GDPR-compliant data set.

10:16am: Only five minutes later, the physician hits the submit button to send the filled case to the company’s expert team for review, who is notified via email.

10:41am: The expert located in the Netherlands logs in to ClinFlows decidemedical platform, downloads the CT data from the Czech Republic and starts the analysis and measurements.

12:25pm: Right before lunch, the expert finishes the task and uploads the analysis outcome, i.e., the detailed report containing measurements and screenshots to decidemedical. A notification is automatically sent to the physician straight away.

1:08pm: The Czech physician logs in to decidemedial and reviews the analysis report he uploaded less than 3 hours ago.

Result:

It took the physician just 5 minutes to upload a TAVI case to decidemedical including several hundreds of MegaByte of CT data – and he didn’t even need to install any software. Despite the local distance, after 2 hours and 14 minutes only, a detailed TAVI expert analysis report was made available to him via decidemedical – in an easy, safe and compliant way. This presents a great way to support physicians, leverage medical expertise and offer excellent client service.

How does your team organize case reviews, eligibility checks or similar tasks? What challenges do you face when doing so?

Discuss here or contact us at info(at)clinflows.com

Image: ijeab – de.freepik.com