Obsidio Conformable Embolic: First-in-Human clinical study

Monday, March 6, 2023

3:36 PM – 3:45 PM

Location: 227ABC

Author/Co-author(s)

FG

Fatih Gulsen, MD

Professor and Consultant
Istanbul University Cerrahpasa Medical Faculty
CS

Cesur Samanci, MD

Assistant Professor
Istanbul University Cerrahpasa Medical Faculty
CD

Cetin Demirdag, MD

Medical Faculty, Professor, Urology
Istanbul University Cerrahpasa
EJ

Ehsan Jabbarzadeh, PhD, MBA

CEO
Obsidio, Inc
Hassan Albadawi, MD

Assistant Professor
Mayo Clinic Arizona
HS

Haluk Sayman, MD

Professor
Istanbul University Cerrahpasa Medical Faculty
SG

Seyda Gunduz, MD

Associate Professor
Antalya Memorial Hospital

Presenting Author(s)

Rahmi Oklu, MD, PhD (he/him/his)

Professor
Mayo Clinic Arizona

Disclosure information not submitted.

Purpose/Objective
Obsidio Conformable Embolic (OCE) is a novel ready-to-use semi-solid embolization agent. Extensive preclinical studies have demonstrated it can be easily injected using most clinical microcatheters, is visible under X-ray and CT without artifact, is biocompatible and can achieve long term durable vascular occlusion. The purpose of this study was to evaluate its safety and performance in a first-in-human (FIH) feasibility study.

Materials & Methods
In this open-label, prospective, FIH study, OCE was used for preoperative embolization of renal cell carcinoma (7.4 cm +/- 5.2 cm; n=5). The study included patients (43-65 y/o; female) presenting for embolization prior to nephrectomy. Technical success, ease of use, histology, imaging pre/post-nephrectomy at day 1-7, and laboratory values were assessed. Any adverse events and performance characteristics were noted.

Results
OCE delivery was successful in all cases achieving instant occlusion of the embolized arteries. All procedures were deemed successful with no adverse events. Procedures were performed under local anesthesia with total procedure times < 30 min. Subsequent nephrectomies were performed with minimal blood loss. CT imaging post-procedure demonstrated no evidence of migration or recanalization of OCE. There were no significant changes in laboratory values (P>0.05) and volume of OCE within embolized arteries (P>0.05) pre and post-embolization procedure. On histology, OCE was noted within occluded renal arteries with no evidence of recanalization.

Conclusion
OCE is safe and easy to use achieving immediate occlusion of the embolized arteries, thus conferring many advantages over current technologies.