A milestone reached EASYX I trial closed successfully
COVID-19 has created challenges in every aspects of healthcare. Due to the current pandemic, the medical device industry has been under tremendous pressure to deliver and innovate. Second most disturbing evolution is the fact, that COVID-19 pandemic has delayed clinical trials and disrupted the CE mark or FDA product submissions what resulted in prolonged product approval timelines.
Qmedics and their KOL managed to close the clinical trial “EASYX I “
Thanks to the fast enrolment of EASYX I trail coordinated by Prof. MD. M. Sapoval supported by the two investigators MD. R.Loffroy and MD. V.Vidal the trial didn’t have any delay due to the COVID -19 pandemic.
Furthermore, the EASYX I article is submitted to JVIR.
Qmedics is happy to share some insides,
Safety and Efficacy of Peripheral Embolization with EASYX™ liquid agent: a multicenter prospective study
EASYX 1 study
Rationale and Objectives: The objectives of this prospective multicentric study was to evaluate the safety and efficacy of EASYX™, a new liquid embolic agent consisting in PVA grafted with iodine molecules for peripheral embolization.
Patients and Methods: We conducted an open-label prospective multicentric study, on 50 consecutive patients in 3 academic hospitals. Indication for embolization was symptomatic varicocele (n = 15), angiomyolipoma
(AML; n = 2), type 2 endoleak (n = 8), acute bleeding (n = 16), or portal vein embolization (PVE; n = 9). Patient characteristics, technical and clinical success, pain at injection and IR satisfaction were assessed. Follow-up imaging was performed using ultrasound for varicoceles (1 month) and CT-scan for the other indications (3 or 6 months).
Results: In this prospective multicenter study, promising results using EASYX™ for embolization in various clinical situations were reported. The results reflect the global satisfaction of the IRs while using the device. The fact that EASYX™ is a ready-to-use device was one positive feature, allowing potentially faster intervention in contrast to need for 20 minutes shaking required before injection for other copolymers such as Onyx or Squid use. This aspect can be advantageous when a very rapid administration is necessary, especially for acute bleeding patients.
- Immediate technical success was obtained in 49 (98%) of the 50 patients and IR satisfaction was >90% for EASYX™ ease of use, ease of injection, cohesivity and overall angiographic results
- Clinical success was 100 % for acute bleeding and type 2 endoleak embolization with absence of artifacts on imaging allowing monitoring of the aneurysmal sac in patients treated for type 2 endoleak.
- We reported > 98% technical success and 100% clinical success on imaging follow-up at 6 months, with no complication, for type II endoleaks embolization, which is better than the results mostly reported
- Clinical success was 85.7 % in patients presenting with varicocele. PVE patients showed a significant hypertrophy of future remnant liver at
FU (p < 0.001) and 5/9 patients could undergo preplanned hepatectomy. IR satisfaction was > 90 % for EASYX™ ease of use, ease of injection, cohesivity and overall angiographic results.
- We also described a good efficacy of embolization for painful varicoceles with a drastic decrease of the VAS score
- The absence of artifacts on CT allowed precise measurement of the sac and evaluation of persistent endoleak during follow-up, which is very helpful for optimal surveillance of the aneurysm
Conclusions: In conclusion, the uses of EASYX™ as the main liquid embolic agent for embolization was safe and efficient . The safety and performance results of EASYX™ were more than satisfactory in this initial prospective multicenter trial. Absence of CT imaging artifacts (no tantalum powder in the device) allowed optimal follow-up of type II endoleaks, representing a major advantage over other liquid embolic agents.
ClinicalTrials.gov Identifier: NCT03477149