Recruiting

TULSA-PRO

Sponsor:

Profound Medical Inc.

Code:

NCT05001477

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Benign Prostatic Hyperplasia

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TULSA Procedure

Study Details

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.

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Benign Prostatic Hyperplasia

Study ID

NCT05001477

Start date

Oct 27, 2021

Status verified date

Nov, 2023

Completion date

Oct, 2061

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

TULSA Procedure

Transurethral ultrasound ablation procedure

Primary outcome measure

  • Rate of complications [ Time Frame: 5 years ]
  • Freedom from treatment failure [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Gina Clarke

416-689-8156gclarke@profoundmedical.com

Arthi Rajamohan

647-476-1350arajamohan@profoundmedical.com

Locations

RadNet's Liberty Pacific West Hills Facility

Recruiting

West Hills, California, United States, 91307

Contacts

Kristi Maya

562-981-6101Kristi.Maya@radnet.com

Rachel Francisco Danas

562-459-3541Rachel.FranciscoDanas@radnet.com

Principal Investigator:

Robert Princenthal, MD

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Ann Dunshee

904-953-5102Dunshee.Ann@mayo.edu

Principal Investigator:

Chandler Dora, MD

Wellspan Health

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Sherrie Keller

717-741-8042skeller@wellspan.org

Principal Investigator:

Edward Steiner, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Anna Manning-Mortimer

904-953-5102Anna.Manning-Mortimer@UTSouthwestern.edu

Principal Investigator:

Daniel Costa, MD

Urology Place

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Victoria Sarwan

210-617-3670victoria@theupi.com

Naveen Kella, MD

210-617-3670nkella@theupi.com

Principal Investigator:

Naveen Kella, MD

More Information

Sponsor

Profound Medical Inc.

Last update posted

Nov 6, 2024

Last verified

Nov, 2023

Keywords

  • Prostate ablation
  • high intensity transurethral ultrasound ablation
  • MRI-guided
  • minimally invasive
  • real-time temperature feedback control
  • prostate cancer
  • BPH
  • TULSA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Profound Medical Inc. on 2024-11-06.