Simplifying blood collection: inside the success of Loop Medical's “painless” study

In July 2022, the Loop Medical team landed in Johannesburg, South Africa for their first clinical study.

The goal was to test Loop Medical’s new painless and simplified blood collection device: Onflow.

Onflow scored outstanding numbers: 97.5% success rate in collecting samples, 95-100% precision, and 99.8% compatibility with Roche Cobas analyzers.

The best part? Participants rated the device as having little to no pain, and 87.5 % were willing to retry it (compared to 41.5% for the traditional needle-and-syringe system!)

How did Onflow achieve this? And what does this mean for the future of clinical trials?

Let’s hear it from Loop Medical’s Clinical Affairs Manager, Alison Moran.

Why did you choose South Africa? And why was it interesting for the host center?

“Our initial round of funding came from the Bill & Melinda Gates Foundation. They thought that Onflow can be used in developing countries and help them have access to healthcare.

“Despite South Africa not being a developing country, it was in Africa and relied on blood testing for infectious diseases.

“The center is in Wits University Medical School and they research infectious diseases like HIV and malaria. They thought the device would help them collect samples when they cannot have a phlebotomist.

“Loop Medical partnered with iLead who’s also funded by Gates Foundation and is interested in infectious diseases that affect people in Africa. It was a good fit. So we embarked on the study.”

What was the objective? And what challenges did you face?

“The main goal was to collect as many samples as we could using Onflow. One of the challenges was reliable data collection. We trained the staff on how to handle the device and set up on-site logistics to make sure everything is organized.

“After the training period, the device was super easy and smooth to use, and the study was well-planned. We didn’t face any major issues.

“We were able to anticipate issues ahead of time and even troubleshoot from our headquarters in Switzerland.”

How did phlebotomists and nurses respond to using Onflow?

“The staff were super excited to use the device. They all thought ‘this is easy. It’s fast. I know how it works.’ It was a combination of trying new technology and seeing how the patient will respond.”

How was the recruitment process?

“All participants were healthy volunteers and they were university staff. We didn’t say no to anyone, and we conducted the study with 100 participants.”

What training did the staff need? And was using Onflow a burden for the lab?

“Onflow is simple and requires minimal training, and that's one of the biggest benefits. So we had a video to show them how the device works. And we had Loop team members on-site to answer questions if something came up.

“The lab processed the samples just as they would with any other sample that came across their lab bench. It was no additional work and no learning curve for them since the sample was the same as the standard of care.”

How did you ensure the accuracy and quality of data?

“Onflow is the simpler alternative to venipuncture – but in order to claim this we had to prove it. So first, we had a phlebotomist collect samples to cross-check.

“The analyzers themselves also had quality control, so the lab was able to see if something went wrong.

“Finally, we had the computer element. We could look at the lab sheet and the data from the analyzer and confirm the reliability of the device.”

How was the atmosphere in the waiting room?

“Some people were surprised that it took 2-6 minutes to collect the blood painlessly from the arm – they thought it was long.

“But in retrospect, the feedback was positive. Each patient filled out a questionnaire after the procedure and responses favored the device over venipuncture. They described Onflow as painless and easy to use.“

What do you think would change on a larger scale?

“I think the more people we include, the more abnormal values we’ll have. This is important because this could mean the device could be used for diagnostics. We’re now looking to push the limits to see what the device could detect.”

What do you think the outcome would be using the alternative (venipuncture or fingerpricks)?

“The reliability goes away. Sadly, other means of collecting blood are limiting and would fall short.

“Onflow not only removes barriers to testing – which is something I'm passionate about – but also allows patients to have better and faster diagnoses.

“You could do a fingerprick instead, but you'll have better quality and more reliable results with Onflow’s high volume.”

How do you see Onflow contributing to the development of personalized medicine?

“I see it happening in an almost backward way. We’re hoping that we can keep running studies and keep publishing the success of Loop Medical, and then someone could walk into the doctor's clinic and say ‘I hate fasting for this blood test I need to do next week, can’t I just use Onflow instead?’

“The more we get the word out, the more we’ll allow people to personalize their own medical care.”

Are there any plans for the next study?

“Yes! We are planning two studies this year. We’ll use those to support our FDA submission and US market entry. It’ll be more focused on a population of patients more representative of the US.”

How did this study impact you as a Clinical Affairs Manager?

“It was a long road for us with regulations and trying to get the device in hand. For me, it was a success that we easily recruited 100 people and we got really great data. This is what fuels my fire – now I’m ready for the next one.

“I’m asking R&D every week if we can have devices sooner and if we can have more devices. So for me, it’s such a great foundation.”

How do you see the field of clinical trials using blood samples evolving in the future?

"I think COVID was a masterclass in decentralization. No one wanted to leave home, even though we had to get tested. The pandemic threw everyone into the deep end saying: remote, precise healthcare is here.

“Now people are practicing telehealth and telemedicine more than ever. And with Onflow, you have blood draws that are reliable, you’re able to do all the tests the doctor asks for, from the comfort of your home without a phlebotomist. I would go with that.

“It’s not just decentralization of healthcare, but decentralization of high-quality healthcare.”

Interested in a pilot using Onflow? Get in touch today.