NCT05201131

Brief Summary

To document the clinical outcome of Rezūm 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
50

participants targeted

Target at P25-P50 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 7, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1.9 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

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

4.2 years

First QC Date

November 27, 2021

Last Update Submit

January 7, 2022

Conditions

Urologic Diseases

Keywords

benigh prostate hypertrophy

Outcome Measures

Primary Outcomes (30)

  • Maximum flow rate (Q-max)

    Maximum flow rate (Q-max)

    Baseline

  • Change of Maximum flow rate (Q-max)

    Change of Maximum flow rate (Q-max)

    1 month after surgery

  • Change of Maximum flow rate (Q-max)

    Change of Maximum flow rate (Q-max)

    3 months after surgery

  • Change of Maximum flow rate (Q-max)

    Change of Maximum flow rate (Q-max)

    6 months after surgery

  • Change of Maximum flow rate (Q-max)

    Change of Maximum flow rate (Q-max)

    12 months after surgery

  • Change of Maximum flow rate (Q-max)

    Change of Maximum flow rate (Q-max)

    24 months after surgery

  • Change of Maximum flow rate (Q-max)

    Change of Maximum flow rate (Q-max)

    36 months after surgery

  • Post-Void Residual (PVR) volume

    Post-Void Residual (PVR) volume

    Baseline

  • Change of Post-Void Residual (PVR) volume

    Change of Post-Void Residual (PVR) volume

    1 month after surgery

  • Change of Post-Void Residual (PVR) volume

    Change of Post-Void Residual (PVR) volume

    3 months after surgery

  • Change of Post-Void Residual (PVR) volume

    Change of Post-Void Residual (PVR) volume

    6 months after surgery

  • Change of Post-Void Residual (PVR) volume

    Change of Post-Void Residual (PVR) volume

    12 months after surgery

  • Change of Post-Void Residual (PVR) volume

    Change of Post-Void Residual (PVR) volume

    24 months after surgery

  • Change of Post-Void Residual (PVR) volume

    Change of Post-Void Residual (PVR) volume

    36 months after surgery

  • Prostate Volume measured by transrectal ultrasound (TRUS)

    Prostate Volume measured by transrectal ultrasound (TRUS)

    Baseline

  • Change of Prostate Volume measured by transrectal ultrasound (TRUS)

    Change of Prostate Volume measured by transrectal ultrasound (TRUS)

    12 months after surgery

  • Questionnaire

    IPSS

    Baseline

  • Change of Questionnaire

    Change of IPSS score

    1 month after surgery

  • Change of Questionnaire

    Change of IPSS score

    3 months after surgery

  • Change of Questionnaire

    Change of IPSS score

    6 months after surgery

  • Change of Questionnaire

    Change of IPSS score

    12 months after surgery

  • Change of Questionnaire

    Change of IPSS score

    24 months after surgery

  • Change of Questionnaire

    Change of IPSS score

    36 months after surgery

  • Adverse Events

    Adverse Events

    Baseline

  • Change of Adverse Events

    Change of Adverse Events

    1 month after surgery

  • Change of Adverse Events

    Change of Adverse Events

    3 months after surgery

  • Change of Adverse Events

    Change of Adverse Events

    6 months after surgery

  • Change of Adverse Events

    Change of Adverse Events

    12 months after surgery

  • Change of Adverse Events

    Change of Adverse Events

    24 months after surgery

  • Change of Adverse Events

    Change of Adverse Events

    36 months after surgery

Study Arms (1)

Rezum procedure

Procedure: Rezum

Interventions

RezumPROCEDURE

Rezum

Rezum procedure

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsself-representation
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Male subjects of ≥ 18 years of age. * Primary diagnosis of Benign Prostate Hypertrophy (BPH). * Candidate for or have already completed Rezūm therapy as per clinical decision of Investigator.

You may qualify if:

  • 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

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

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Dean Elterman

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Chan

CONTACT

416-603-5800iris.chan2@uhn.ca

Dean Elterman

CONTACT

141660358005033dean.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

January 21, 2022

Study Start

October 7, 2019

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2026

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

CA(1)