NCT05169892

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Oct 2019Dec 2026

Study Start

First participant enrolled

October 9, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 27, 2021

Status Verified

December 1, 2021

Enrollment Period

4.2 years

First QC Date

November 27, 2021

Last Update Submit

December 9, 2021

Conditions

Urologic Diseases

Keywords

benigh prostate hypertrophy

Outcome Measures

Primary Outcomes (31)

  • Maximum flow rate (Q-max)

    Standard of care

    Baseline

  • Post-Void Residual (PVR) volume

    Standard of care

    Baseline

  • Maximum flow rate (Q-max)

    Standard of care

    1 month after surgery

  • Post-Void Residual (PVR) volume

    Standard of care

    1 month after surgery

  • Maximum flow rate (Q-max)

    Standard of care

    3 months after surgery

  • Post-Void Residual (PVR) volume

    Standard of care

    3 months after surgery

  • Maximum flow rate (Q-max)

    Standard of care

    6 months after surgery

  • Post-Void Residual (PVR) volume

    Standard of care

    6 months after surgery

  • Maximum flow rate (Q-max)

    Standard of care

    12 months after surgery

  • Post-Void Residual (PVR) volume

    Standard of care

    12 months after surgery

  • Maximum flow rate (Q-max)

    Standard of care

    24 months after surgery

  • Post-Void Residual (PVR) volume

    Standard of care

    24 months after surgery

  • Maximum flow rate (Q-max)

    Standard of care

    36 months after surgery

  • Post-Void Residual (PVR) volume

    Standard of care

    36 months after surgery

  • Prostate Volume

    Standard of care

    Baseline

  • Prostate Volume

    Standard of care

    12 months after surgery

  • Questionnaires

    IPSS

    Baseline

  • Questionnaires

    IPSS

    1 month after surgery

  • Questionnaires

    IPSS

    3 months after surgery

  • Questionnaires

    IPSS

    6 months after surgery

  • Questionnaires

    IPSS

    12 months after surgery

  • Questionnaires

    IPSS

    24 months after surgery

  • Questionnaires

    IPSS

    36 months after surgery

  • Adverse Events

    Adverse Events

    Baseline

  • Adverse Events

    Adverse Events

    1 day of Surgery

  • Adverse Events

    Adverse Events

    1 month after surgery

  • Adverse Events

    Adverse Events

    3 months after surgery

  • Adverse Events

    Adverse Events

    6 months after surgery

  • Adverse Events

    Adverse Events

    12 months after surgery

  • Adverse Events

    Adverse Events

    24 months after surgery

  • Adverse Events

    Adverse Events

    36 months after surgery

Study Arms (1)

Aquablation

Procedure: Aquablation

Interventions

AquablationPROCEDURE

Aquablation

Aquablation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

BPH patients treated by Aquablation

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dean Elterman

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Urologic Diseases

Interventions

Aquablation

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Central Study Contacts

Dean Elterman

CONTACT

4166035800dean.elterman@uhn.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urologist

Study Record Dates

First Submitted

November 27, 2021

First Posted

December 27, 2021

Study Start

October 9, 2019

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2026

Last Updated

December 27, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)