Patients who elect for the Tulsa-Pro procedure will also have the opportunity to participate in the Customized TULSA-PRO Ablation Registry (CARE Registry) trial.
A registry is a place where medical information related to your prostate cancer treatment is collected and stored for the purpose of conducting medical research. The purpose of this research is to capture and store information on patients who are undergoing or who have undergone the TULSA Procedure as part of their routine clinical care so that real-world outcomes of safety and efficacy of the TULSA-PRO system can be verified. The ultimate goal of this research study is to improve patient care and quality of life while increasing scientific knowledge of prostate treatment options and associated costs.
Patients who are part of the CARE Registry will have their medical information and quality of life collected and stored in a private and secure electronic data capture (EDC) system. The registry will be active for a minimum of 5 years. However, as the purpose of the registry is to collect real-world outcomes of safety and efficacy of the TULSA Procedure, there is no fixed end to the study. Participants will be encouraged to attend as many annual follow up visits with their referring physician as possible, but can withdraw from the study at any time.
Participation in this registry will provide the patient with closer monitoring of their prostate and general health while enabling all TULSA-PRO Centers to advance their knowledge of prostate treatment. Ultimately, this may help improve the future care and quality of life of many other patients with prostate disease.
For more information about this trial go to www.Clinical Trials.gov https://clinicaltrials.gov/ct2/show/NCT05001477?term=Profound+Care+registry&cond=Prostate+Cancer&cntry=US&draw=2&rank=1
ClinicalTrials.gov identifier (NCT number): NCT05001477
Or contact our research team at [email protected]