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Recruiting

NCT Number: NCT05169892

Aquablation in Benign Prostatic Hyperplasia in Canada

To document the clinical outcome of Aquablation 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

About this study

Patients will be followed up for 3 years as standard of care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary diagnosis of Benign Prostate Hypertrophy (BPH)
  • Male subjects of ≥ 18 years of age
  • Candidate for Aquablation therapy as per clinical decision of Investigator
  • Willing and able to accurately complete 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

Aquablation

Procedure

Aquablation

Primary outcomes

  1. Maximum flow rate (Q-max)

    Time frame: Baseline

    Standard of care

  2. Post-Void Residual (PVR) volume

    Time frame: Baseline

    Standard of care

  3. Maximum flow rate (Q-max)

    Time frame: 1 month after surgery

    Standard of care

  4. Post-Void Residual (PVR) volume

    Time frame: 1 month after surgery

    Standard of care

  5. Maximum flow rate (Q-max)

    Time frame: 3 months after surgery

    Standard of care

  6. Post-Void Residual (PVR) volume

    Time frame: 3 months after surgery

    Standard of care

  7. Maximum flow rate (Q-max)

    Time frame: 6 months after surgery

    Standard of care

  8. Post-Void Residual (PVR) volume

    Time frame: 6 months after surgery

    Standard of care

  9. Maximum flow rate (Q-max)

    Time frame: 12 months after surgery

    Standard of care

  10. Post-Void Residual (PVR) volume

    Time frame: 12 months after surgery

    Standard of care

  11. Maximum flow rate (Q-max)

    Time frame: 24 months after surgery

    Standard of care

  12. Post-Void Residual (PVR) volume

    Time frame: 24 months after surgery

    Standard of care

  13. Maximum flow rate (Q-max)

    Time frame: 36 months after surgery

    Standard of care

  14. Post-Void Residual (PVR) volume

    Time frame: 36 months after surgery

    Standard of care

  15. Prostate Volume

    Time frame: Baseline

    Standard of care

  16. Prostate Volume

    Time frame: 12 months after surgery

    Standard of care

  17. Questionnaires

    Time frame: Baseline

    IPSS

  18. Questionnaires

    Time frame: 1 month after surgery

    IPSS

  19. Questionnaires

    Time frame: 3 months after surgery

    IPSS

  20. Questionnaires

    Time frame: 6 months after surgery

    IPSS

  21. Questionnaires

    Time frame: 12 months after surgery

    IPSS

  22. Questionnaires

    Time frame: 24 months after surgery

    IPSS

  23. Questionnaires

    Time frame: 36 months after surgery

    IPSS

  24. Adverse Events

    Time frame: Baseline

    Adverse Events

  25. Adverse Events

    Time frame: 1 day of Surgery

    Adverse Events

  26. Adverse Events

    Time frame: 1 month after surgery

    Adverse Events

  27. Adverse Events

    Time frame: 3 months after surgery

    Adverse Events

  28. Adverse Events

    Time frame: 6 months after surgery

    Adverse Events

  29. Adverse Events

    Time frame: 12 months after surgery

    Adverse Events

  30. Adverse Events

    Time frame: 24 months after surgery

    Adverse Events

  31. Adverse Events

    Time frame: 36 months after surgery

    Adverse Events

Study contacts

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

Dean Elterman

CONTACT

[email protected]

4166035800 ext. 5033

Sponsors and collaborators

Lead sponsor

Can-Am HIFU Inc.

Other

Registry information

Official study title

Canadian Cohort of Aquablation, a Robotically Executed, Surgeon-guided, High-pressure Water Jet Ablation Therapy for Endoscopic Resection of Prostate Tissue, in Benign Prostatic Hyperplasia (BPH).

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Dec 27, 2021
Registry last updated
Dec 27, 2021

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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