Spots Global Cancer Trial Database for Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer
Official Title: Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study
Study ID: NCT02766543
Conditions
Interventions
Study Description
Brief Summary: A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
Detailed Description: Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system (TULSA-PRO). The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue. The treatment is conducted within a MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland. It provides advantages of a non-invasive procedure with short treatment times.
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of California Los Angeles, Los Angeles, California, United States
Yale Cancer Centre, New Haven, Connecticut, United States
University of Chicago, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
Johns Hopkins Medicine, Baltimore, Maryland, United States
William Beaumont Hospital, Royal Oak, Michigan, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
London Health Sciences Centre, London, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Hospital of Cologne, Cologne, , Germany
Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology), Heidelberg, , Germany
Radboud University Medical Center, Nijmegen, , Netherlands
ResoFus Alomar (Hospital Universitari De Bellvitge), Barcelona, , Spain
Contact Details
Name: Scott Eggener, MD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
