MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

RecruitingOBSERVATIONAL
Enrollment

5,000

Participants

Timeline

Start Date

November 15, 2020

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2038

Conditions
Neoplasms ProstateCancer of the Prostate
Interventions
DEVICE

Image Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer

Subjects diagnosed by a transperineal fusion or random transperineal or random transrectal prostate biopsy. Laser treatment plan generated by biopsy results +/- MRI is uploaded into the device. In procedure suite, a transperineal anesthetic block is conducted following by Bianco - USPTO PCT/US18/24404. On lithotomy a transrectal ultrasound probe is advanced, the prostate scanned. The images are acquired by fusion device. Co-registration is performed by surgeon delimiting boundaries of prostate. Medical device delivers real-time fusion guidance outlining prostate contours, ablation goals and laser introduce location. Surgeon executes plan or adjust as needed. Surgeon activates laser device, performs ablation monitored by medical device in real-time. The fusion device will deliver great perspective between the ablation areas and critical anatomical landmarks such as: NVB, membranous urethra, etc. Patient is dismissed to the recovery room and discharged afterwards

Trial Locations (1)

33016

RECRUITING

Urological Research Network, Miami Lakes

All Listed Sponsors
lead

Urological Research Network, LLC

OTHER