Customized TULSA-PRO Ablation Registry
CARE
1 other identifier
observational
1,000
1 country
5
Brief Summary
This patient registry will capture data from patients who have been or who are undergoing the transurethral ultrasound ablation (TULSA) procedure as part of their routine clinical care. The registry will shed light on real-world outcomes of safety and efficacy of the procedure and understand how a patient's quality of life is affected throughout their follow-up and lifetime.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedStudy Start
First participant enrolled
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2061
November 6, 2024
November 1, 2023
4.9 years
May 13, 2021
November 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of complications
estimating the rate of complications (Clavien-Dindo grades III - IV) attributable to the TULSA Procedure
5 years
Freedom from treatment failure
Estimating the proportion of patients who are free from primary treatment failure after the TULSA Procedure.
5 years
Secondary Outcomes (18)
Complications Data
Lifelong up to 99 years
Biopsy Data
Between 6 and 18 months post TULSA Procedure
Prostate Volume Reduction on MRI
Between 6 and 18 months post TULSA Procedure
Suspicious cancerous lesions on MRI
Between 6 and 18 months post TULSA Procedure
PSA Data
Lifelong up to 99 years
- +13 more secondary outcomes
Interventions
Transurethral ultrasound ablation procedure
Eligibility Criteria
This study will include as many eligible subjects as willing to participate who have undergone or will be undergoing the TULSA Procedure.
You may qualify if:
- Male
- \>18 years old
- Candidate for TULSA-PRO treatment
- willing and able to sign the Informed Consent form
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
RadNet's Liberty Pacific West Hills Facility
West Hills, California, 91307, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Wellspan Health
York, Pennsylvania, 17403, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Urology Place
San Antonio, Texas, 78240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 40 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2021
First Posted
August 12, 2021
Study Start
October 27, 2021
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2061
Last Updated
November 6, 2024
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share