SterileCare Inc. Reaches Key Enrollment Milestone in Innovative Catheter Lock Solution Trial
dicentra congratulates SterileCare on achieving a significant milestone in their innovative catheter lock solution clinical trial, with 20 patients enrolled as of December 30, 2024. The trial, which enrolled its first patient in June 2024 at Cincinnati Children’s Hospital, continues to make steady progress toward its goal of 124 participants.
CINCINNATI, OH / ACCESSWIRE / January 6, 2025 / SterileCare’s trial, which received Investigational Device Exemption (IDE) approval on April 20, 2023, and Institutional Review Board (IRB) approval on July 13, 2023, aims to evaluate the safety and effectiveness of a catheter lock solution in preventing catheter occlusion in pediatric patients with intestinal failure. It focuses on catheter occlusions, a prevalent non-infectious complication in the long-term use of central venous access devices (CVADs). The hypothesis is that a 4% Tetrasodium EDTA lock will be more effective at preventing CVC occlusions than the standard heparin lock.
dicentra is providing essential CRO support to SterileCare throughout this trial. This includes site management, monitoring, data management, project management, statistical analysis, and Electronic Data Capture (EDC) setup, ensuring the trial adheres to regulatory standards and achieves high-quality benchmarks.
Peter Wojewnik, Managing Partner at dicentra, commented, “Partnering in a trial that aims to deliver meaningful and life-changing therapies to patients is both a privilege and a vital part of our mission. Our role is to help clients like SterileCare bring their innovative solutions to those who need them most.”
Karen Mueller, Chief Executive Officer at SterileCare, commented, “We are pleased to sponsor this pivotal clinical trial and partner with dicentra as the CRO. SterileCare provides a solution that bridges a clinical gap for patients requiring vascular access devices for lifesaving treatments such as dialysis, chemotherapy, and TPN for children with intestinal failure. If these catheters become blocked, patient treatment regimens are interrupted, leading to complications. SterileCare’s top priority is to improve the function of these catheters so patients and families can focus on getting better and living their best lives, rather than worrying about complications.”
Dr. Paul Wales, Surgical Director of the Intestinal Rehabilitation Program at Cincinnati Children’s and Lead Investigator for the study, commented, “Maintaining vascular patency in our patients who have long-term central venous catheters is imperative. Prevention of occlusions as well as bloodstream infections is of tremendous prognostic importance. This trial has the potential to significantly impact outcomes for our children on home parenteral nutrition.”
About dicentra: dicentra is a leading Contract Research Organization (CRO) and global consulting firm specializing in safety, quality, and compliance for the life sciences and food industries. Since 2002, dicentra has completed over 24,000 projects and served more than 1,400 companies internationally through its consulting and clinical trial divisions. For more information, visit https://dicentra.com.
About SterileCare: SterileCare is a Canadian medical device company that provides safe and effective solutions that significantly impact preventable complications and the associated financial burden of healthcare-acquired complications. SterileCare’s flagship solution, KiteLock™ 4% catheter lock solution, is a revolutionary product in the fight against complications arising from Central Venous Access Devices (CVADs). Our goal is to help patients focus on improving their health rather than on complications related to their treatment. For more information, visit https://sterilecareinc.com.
CONTACT:
Kory Punkkinen, HBSc
Director of Growth and Strategic Partnerships
1-416-361-3400 Ext. 254
TF: 866-647-3279 Ext. 254
dicentra
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www.dicentra.com
SOURCE: dicentra
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