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MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer
Sponsor: Urological Research Network, LLC
Summary
This serves as a registration trial. It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. Outcomes will be categorized as: 1- Procedure Related, 2- Perioperative - Adverse Events that may occur within 90 days, 3-Oncologic: Recurrence of cancer in treatment area, de-novo tumors, conversion to radical surgery, radiation or cryoablation, emergence of metastasis, 4- Functional: Sexual and Urinary function following treatment
Official title: Office Based MRI/Ultrasound Guided Prostate Cancer Ablation: Outcomes Registry
Key Details
Gender
MALE
Age Range
50 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2020-11-15
Completion Date
2038-11
Last Updated
2023-01-26
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Urological Research Network
Miami Lakes, Florida, United States