Registry for patients undergoing TULSA procedure for prostate conditions
Customized TULSA-PRO Ablation Registry
This study is tracking patients who have had the TULSA procedure for prostate issues to see how safe and effective it is and how it affects their quality of life over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Profound Medical Inc. Academic / other |
| Locations | 5 sites (West Hills, California and 4 other locations) |
| Trial ID | NCT05001477 on ClinicalTrials.gov |
What this trial studies
This registry collects data from patients who are undergoing or have undergone the transurethral ultrasound ablation (TULSA) procedure for prostate cancer and benign prostatic hyperplasia. The aim is to evaluate the real-world safety and efficacy of the TULSA procedure, as well as its impact on patients' quality of life over time. Patients will be followed up at regular intervals for several years, providing valuable insights into treatment outcomes and practice trends. The registry will help optimize patient care based on collected evidence.
Who should consider this trial
Good fit: Ideal candidates are males over 18 years old who are candidates for the TULSA-PRO treatment.
Not a fit: Patients who are not candidates for the TULSA procedure will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of TULSA outcomes, leading to improved patient care and quality of life.
How similar studies have performed: Other studies on similar minimally invasive procedures have shown promising outcomes, indicating potential for success in this registry.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Male 2. \>18 years old 3. Candidate for TULSA-PRO treatment 4. willing and able to sign the Informed Consent form Exclusion Criteria: None.
Where this trial is running
West Hills, California and 4 other locations
- RadNet's Liberty Pacific West Hills Facility — West Hills, California, United States (Recruiting)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Wellspan Health — York, Pennsylvania, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Urology Place — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Gina Clarke
- Email: gclarke@profoundmedical.com
- Phone: 416-689-8156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.