Patients who have already undergone, or are planning to undergo treatment with the TULSA-PRO system are invited to participate in a research study called the Customized TULSA-PRO Ablation Registry (CARE Registry).
A registry is a place where medical information related to your prostate and treatment is collected and stored for the purpose of conducting future medical research.
What is the purpose of the CARE Registry?
The purpose of this CARE Registry 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.
What happens when I am part of the Registry?
If you agree to participate in the Registry, information about your prostate health, general health, and quality of life will be collected. You will be encouraged to attend as many follow-up visits as possible (either in person, via an online portal, via telephone consultation, or via letter mail) but can withdraw from the study at any time.
During your follow-up visits, you will be asked to complete a questionnaire (~10 min long) pertaining to your health. These visits will occur at baseline, 3-month, 6-month, 12-month, 2 years and every year thereafter post-treatment. Information will be gathered from your existing medical records about any assessments that have been done, such as MRIs, biopsies, PSA tests, metastases evaluations and uroflowmetry. Additionally, the study team will ask about any complications you have experienced since your TULSA-PRO procedure and whether you have undergone any additional treatments for your prostate.
The information that is collected will be 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.
Your participation in this registry will provide you with better medical care through closer monitoring of your prostate and general health while enabling all TULSA-PRO Centers to advance their knowledge of prostate treatment. Ultimately, this will help improve the future care and quality of life of many others who struggle with prostate disease.
- Older than 18 years old
- Candidate for TULSA-PRO procedure
- Willing and able to sign and date this consent form
To learn more about the eligibility criteria, click here: https://clinicaltrials.gov/ct2/show/NCT05001477
You may be compensated or reimbursed for your time in the study after the completion of every follow-up visit and questionnaire.