N Kohli, A Blitzer, A Jahn, YJ Cho, J Budrewicz, K Enos, M Strome. “Safety and Feasibility of a Novel Esophageal Balloon for Circumferential Cytologic Sampling.”
A prior publication introduced the Strome-Blitzer balloon’s ability to obtain circumferential esophageal cytologic sampling. This GLP study was requisite for FDA approval to determine if equivalent cell capture and cellularity was observed with the balloon compared to surface sampling brushes and to determine the balloon’s usability for naive otolaryngologists.
Three naïve users tested the Hobbs brush and Strome-Blitzer balloon on 4 Yorkshire swine. Four anatomical sites were sampled, beginning distally and ending proximally.
Results: There was no device malfunction, mucosal trauma, or difficulty with device use. Balloon cytologic samples were comparable in cellularity and quality to the brush.
Conclusion: A single balloon sampling was comparable to 4 brushes in capturing diagnostically relevant cellular volumes and architecture. Naïve users easily performed the procedures after reading the guidelines.