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Clinical Trial Summary

This study is a prospective, open label, single-arm study to examine the performance and safety of the SENSEI® laparoscopic tethered gamma probe in patients undergoing 99mTc-nanocolloid SLNB for prostate cancer (PCa) during RP and ePLND surgery. Patients scheduled for RP and ePLND using the standard treatment pathways at each centre will have preoperative 99mTc-nanocolloid imaging. RP and ePLND will be conducted as standard of care, with SLNB guided by the SENSEI® laparoscopic tethered gamma probe carried out after RP and prior to ePLND. The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study. Subsequent patients will be evaluable for the PP population. The primary analysis of diagnostic performance will be performed using the PP population of patients with SLN identified on preoperative imaging


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04632251
Study type Interventional
Source Lightpoint Medical Limited
Contact Lluis Fumado Ciutat
Phone +34 650 947 553
Email LFumado@parcdesalutmar.cat
Status Recruiting
Phase N/A
Start date September 16, 2020
Completion date August 2021

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