Actively Recruiting
Customized TULSA-PRO Ablation Registry
Led by Profound Medical Inc. · Updated on 2024-11-06
1000
Participants Needed
5
Research Sites
1826 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting data in a patient registry for men undergoing or who have undergone the transurethral ultrasound ablation (TULSA) procedure as part of their regular medical care. The goal is to better understand real-world safety and effectiveness of TULSA and how it impacts patients' quality of life over time. This observational study includes patients with prostate cancer, prostate adenocarcinoma, or benign prostatic hyperplasia. Participants receive the TULSA procedure as part of their routine treatment. The registry gathers baseline information such as demographics, medical history, prostate MRI, biopsy results, PSA levels, and quality of life questionnaires. Follow-up visits occur at 3 months, 6 months, 12 months, 2 to 5 years, and annually thereafter for life. Data includes treatment assessments, complications, PSA, survival, quality of life, and optional financial tracking. During the study, patients complete questionnaires emailed to them at scheduled visits. Data is securely stored and monitored to ensure accuracy. Outcomes measured include complication rates and freedom from treatment failure over 5 years, with lifelong monitoring for survival, quality of life, PSA, and other health indicators. Participation continues until withdrawal or death, providing valuable long-term insights into TULSA treatment effects and patient experience.
CONDITIONS
Brief Title
Customized TULSA-PRO Ablation Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male
- Over 18 years old
- Candidate for TULSA-PRO treatment
- Willing and able to sign the Informed Consent form
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Day of procedure
Participants undergo the customized transurethral ultrasound ablation (TULSA) procedure as part of their routine clinical care.
1 treatment day visit
Duration - Lifelong up to 99 years
Participants are followed over time through routine clinical care to monitor safety, efficacy, quality of life, and survival outcomes after the TULSA procedure.
Visits at 3 months, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years, and annually thereafter; data collected via questionnaires sent by email
Trial Site Locations
Total: 5 locations
1
RadNet's Liberty Pacific West Hills Facility
West Hills, California, United States, 91307
Actively Recruiting
2
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Wellspan Health
York, Pennsylvania, United States, 17403
Actively Recruiting
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
Urology Place
San Antonio, Texas, United States, 78240
Actively Recruiting
Research Team
G
Gina Clarke
A
Arthi Rajamohan
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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