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NCT Number: NCT05201131

Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).

To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.

Recruiting

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Key information

Conditions

Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subjects of ≥ 18 years of age.
  • Primary diagnosis of Benign Prostate Hypertrophy (BPH).
  • Candidate for Rezūm therapy as per clinical decision of Investigator.
  • Willing and able to accurately complete the required questionnaires.
  • Willing and able to provide signed and dated informed consent

Exclusion criteria

  • Characteristics indicating a poor compliance with study protocol requirements.
  • Disease or other health condition that is not suitable for this study.
  • Unable or unwilling to provide signed informed consent.

Treatment and study plan

Rezum

Procedure

Rezum

Primary outcomes

  1. Maximum flow rate (Q-max)

    Time frame: Baseline

    Maximum flow rate (Q-max)

  2. Change of Maximum flow rate (Q-max)

    Time frame: 1 month after surgery

    Change of Maximum flow rate (Q-max)

  3. Change of Maximum flow rate (Q-max)

    Time frame: 3 months after surgery

    Change of Maximum flow rate (Q-max)

  4. Change of Maximum flow rate (Q-max)

    Time frame: 6 months after surgery

    Change of Maximum flow rate (Q-max)

  5. Change of Maximum flow rate (Q-max)

    Time frame: 12 months after surgery

    Change of Maximum flow rate (Q-max)

  6. Change of Maximum flow rate (Q-max)

    Time frame: 24 months after surgery

    Change of Maximum flow rate (Q-max)

  7. Change of Maximum flow rate (Q-max)

    Time frame: 36 months after surgery

    Change of Maximum flow rate (Q-max)

  8. Post-Void Residual (PVR) volume

    Time frame: Baseline

    Post-Void Residual (PVR) volume

  9. Change of Post-Void Residual (PVR) volume

    Time frame: 1 month after surgery

    Change of Post-Void Residual (PVR) volume

  10. Change of Post-Void Residual (PVR) volume

    Time frame: 3 months after surgery

    Change of Post-Void Residual (PVR) volume

  11. Change of Post-Void Residual (PVR) volume

    Time frame: 6 months after surgery

    Change of Post-Void Residual (PVR) volume

  12. Change of Post-Void Residual (PVR) volume

    Time frame: 12 months after surgery

    Change of Post-Void Residual (PVR) volume

  13. Change of Post-Void Residual (PVR) volume

    Time frame: 24 months after surgery

    Change of Post-Void Residual (PVR) volume

  14. Change of Post-Void Residual (PVR) volume

    Time frame: 36 months after surgery

    Change of Post-Void Residual (PVR) volume

  15. Prostate Volume measured by transrectal ultrasound (TRUS)

    Time frame: Baseline

    Prostate Volume measured by transrectal ultrasound (TRUS)

  16. Change of Prostate Volume measured by transrectal ultrasound (TRUS)

    Time frame: 12 months after surgery

    Change of Prostate Volume measured by transrectal ultrasound (TRUS)

  17. Questionnaire

    Time frame: Baseline

    IPSS

  18. Change of Questionnaire

    Time frame: 1 month after surgery

    Change of IPSS score

  19. Change of Questionnaire

    Time frame: 3 months after surgery

    Change of IPSS score

  20. Change of Questionnaire

    Time frame: 6 months after surgery

    Change of IPSS score

  21. Change of Questionnaire

    Time frame: 12 months after surgery

    Change of IPSS score

  22. Change of Questionnaire

    Time frame: 24 months after surgery

    Change of IPSS score

  23. Change of Questionnaire

    Time frame: 36 months after surgery

    Change of IPSS score

  24. Adverse Events

    Time frame: Baseline

    Adverse Events

  25. Change of Adverse Events

    Time frame: 1 month after surgery

    Change of Adverse Events

  26. Change of Adverse Events

    Time frame: 3 months after surgery

    Change of Adverse Events

  27. Change of Adverse Events

    Time frame: 6 months after surgery

    Change of Adverse Events

  28. Change of Adverse Events

    Time frame: 12 months after surgery

    Change of Adverse Events

  29. Change of Adverse Events

    Time frame: 24 months after surgery

    Change of Adverse Events

  30. Change of Adverse Events

    Time frame: 36 months after surgery

    Change of Adverse Events

Study contacts

Contact information is provided by the study sponsor or research team.

Dean Elterman

CONTACT

[email protected]

141660358005033

Iris Chan

CONTACT

[email protected]

416-603-5800 ext. 5033

Sponsors and collaborators

Lead sponsor

Can-Am HIFU Inc.

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Jan 21, 2022
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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