Introduction:
The Envisioneering TargetScan® is a novel transrectal ultrasound (TRUS) device employing a 3D imaging and targeting system. This device allows the physician to generate a solid image of the prostate without moving the transducer probe. This may greatly facilitate biopsy and treatment planning (brachytherapy and cryotherapy).
This system employs a novel, specially designed 18 gauge (GA) x 20 centimeter (cm) 3-piece Nitinol Bendable Biopsy Needle (NBBN) to sample the prostate. The primary objective of this investigation is to compare the weights of a series of biopsy samples obtained using the NBBN to the specimens obtained by a standard 18GA x 20cm biopsy needle used in current TRUS biopsy procedures.
 Methods:
30 Envisioneering NBBN were fired into a pork loin 30 times each and biopsy samples were weighed. 5 Manan Medical Products, Inc. Pro-Mag 18GA x 20cm biopsy needles were fired into the same pork loin tissue 30 times each and the biopsy samples were likewise weighed. Specimen weights retrieved using each needle were compared.
Results:
Figure 1: Mean and standard deviation of biopsy sample sample weights (SD = Standard Deviation)
The mean weights (and standard deviation) are shown in Figure 1. The average specimen weight obtained using the Manan biopsy needles was 5.0 milligrams (mg). The average specimen weight obtained using the Envisioneering NBBN was 5.2 mg. The 4% greater yield using the NBBN was not statistically significant (p-value 0.43). No sample attempt for either needle failed to obtain tissue. There were no mechanical failures observed with either needle.
Conclusion:
The Envisioneering Nitinol Bendable Biopsy Needle yields comparable specimens in comparison to the standard 18GA prostatic biopsy needles used in routine practice. In addition no mechanical failure or failure in obtaining tissue was noted from the study needle. The combination of the Envisioneering TargetScan® 3D imaging system with this novel Bendable Biopsy Needle may improve our ability to diagnose and characterize prostate cancer.
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Travis L. Bullock1, Erica J. Traxel1, Jay S. Belani1,