First patient enrolled in the RCT ORSY clinical trial

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We are happy to announce the enrollment of the first patient in the RCT ORSY clinical trial. The study aims to demonstrate the benefits of using Obsidian ASG® vs standard treatment in the healing of anastomoses in colorectal surgery. Obsidian ASG® is a bioactive fibrin matrix with sustained release of active cells and growth factors with improved sealing, healing and tissue regeneration capabilities.

The ORSY trial will take place in 7 countries with 15 participating hospitals, including two Belgian centers with Duomed as local partner.

Coordinating Study Investigator is Prim. Priv.-Doz. Dr. Andreas Shamiyeh (Kepler University Hospital Linz). Other collaboration partners are Rivolution (commercial partner), Mag. Andreas Raffeiner (CRO) and AF Schimetta (Statistician). The ORSY study is supported by an EU grant through the EIC Accelerator program.

Anastomotic leakage is a common severe complication after gastrointestinal (GI) surgery affecting morbidity and mortality. Obsidian ASG® is anticipated to save numerous lives and decrease the immense global healthcare costs associated with anastomotic leakages.

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