Vitestro starts largest-scale clinical trial globally for its autonomous blood drawing device, with enrolment of first patients in A.D.O.P.T.

2023-09-06

临床研究

UTRECHT, The Netherlands, Sept. 6, 2023 /PRNewswire/ -- Vitestro, expert in medical robotics, has launched the A.D.O.P.T. Trial for its autonomous blood drawing device (image). With an anticipated sample size of over 10,000 patients, this is the most significant study globally to date of autonomous blood collection. Vitestro expects to obtain CE marking by the end of 2024.

Vitestro starts largest-scale clinical trial globally for its autonomous blood drawing device, with enrolment of first patients in A.D.O.P.T.

Preview

来源: PRNewswire

Patient receiving autonomous blood drawing from Vitestro's device, accompanied by a health professional

The first 350 patients have currently been enrolled the A.D.O.P.T. (Autonomous Optimization and Performance Tests for Blood Testing) Trial at study site Result Laboratorium in the Albert Schweitzer Hospital. Investigational partners, in addition to Result Laboratorium - Albert Schweitzer Hospital, are St. Antonius, OLVG Lab and Amsterdam UMC.

Vitesro's device combines AI-based, ultrasound-guided 3D reconstruction with the robotic insertion of a needle, ensuring accurate, consistent venipuncture. A prototype has previously been tested with 1,500 patients.

In short:

Enrollment of first 350 patients in A.D.O.P.T. Trial

Trial partners: Result Laboratorium at Albert Schweitzer Hospital, St. Antonius Hospital, OLVG Lab, and Amsterdam UMC

CE marking expected by end of 2024

Toon Overbeeke, Founder and CEO at Vitestro, says: "The A.D.O.P.T. Trial is a two-year study. Our objective is to test and continue developing Vitestro's autonomous venipuncture device and achieve performance and safety results required for regulatory approval."

Subsequent to this study, Vitestro expects to obtain CE marking on the device they developed to enable autonomous venipuncture with patients.

Result Laboratorium

Since the beginning of operations in 2017, Result Laboratorium in the Albert Schweitzer Hospital has been collaborating with Vitestro. Michael Fouraux, Principal Investigator at Result Laboratorium, says: "Both patients and phlebotomists are very excited about this particular innovation. The A.D.O.P.T. trial heralds a new phase in which we prepare for implementation in routine clinical practice."

Patients can opt to have their blood drawn by the device and complete the process independently under the supervision of trained healthcare personnel. Fouraux continues: "The degree of professionalism and energy that the Vitestro team brings along really makes a difference and ensures we find our team and patients more than willing to collaborate. Our organizations just click very well together. In recent years, hundreds of patients at this location have already participated in various tests with the blood collection device."

This innovation in phlebotomy will complement the conventional method of collecting blood samples manually. Implemented devices are intended to compensate the shortage of personnel, making it easier to organize the busy Outpatient Blood Draw Clinic.

Albert Schweitzer Hospital

The Albert Schweitzer Hospital is a regional teaching hospital with approximately 50,000 patient admissions per annum (including day treatment) and nearly 300,000 outpatient visits spread across four locations. "We like to be at the forefront of innovation and are therefore proud that Result Laboratorium selected our location in Dordrecht to conduct the A.D.O.P.T. study," says spokesperson Frank van den Elsen. "In our sector, where demand for care is increasing though resources and staffing remain the same, there is a great need for smarter and more efficient operations. Autonomous blood collection can serve a strategic interest in that context."

Vitestro's autonomous blood drawing device contributes to safe, consistent blood collection for patients, and to solving the increasing shortage of healthcare personnel. Upon obtaining CE marking, the technology is expected to be ready to use for patient care in hospitals and laboratories by the end of 2024.

About A.D.O.P.T.

ClinicalTrials.gov ID: NCT05878483

About Result Laboratorium

Result Laboratorium is an independent clinical laboratory in the Southwest Netherlands region. Result provides 24/7, expert and high-quality diagnostics for several hospital sites: Albert Schweitzer Hospital, Amphia Hospital, Beatrix Hospital and Ikazia Hospital. We also serve GPs, midwives, nursing homes and other care workers. In recent years, Result Laboratorium has grown considerably in a market that is in a state of flux. The organization consists of more than 500 employees and covers a large geographical area. The new central laboratory in Zevenbergen, The Netherlands, has recently been completed and is now being made operational. Rapid labs are set up at each hospital site to provide STAT testing.

About Vitestro

Vitestro, an expert in medical robotics, was founded in 2017 to develop a device for autonomous blood collection in patients. The premise for this innovation is to create a safe and consistent patient experience parallel to working towards a positive impact on solving the increasing shortage of healthcare personnel.

The blood collection device combines AI-based, ultrasound-guided 3D reconstruction with venipuncture. The procedure is fully automated, from tourniquet to applying a bandage.

With a zealous team of dedicated specialists, Vitestro tackles the toughest challenges to find the most cutting-edge solutions of our era. Vitestro expects its autonomous phlebotomy technology to be available on the European market by the end of 2024.

Please contact for more information:

Vitestro, Utrecht, The Netherlands

Christine Strik, Marketing and Communications Manager (NL, EN, FR, DE)

T: +31 621 838 634

E: [email protected]

Result Laboratorium, Dordrecht, The Netherlands

Dr. M. A. Fouraux, Principal Investigator A.D.O.P.T., Clinical Chemist

T: +31 786 541 810

E: [email protected]

Albert Schweizer Ziekenhuis, Dordrecht, The Netherlands

Frank van den Elsen, Communications Consultant & Spokesperson

T: +31 786 541 435