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

NCT ID: NCT05201131

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-07

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Urologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rezum procedure

Rezum

Intervention Type PROCEDURE

Rezum

Interventions

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Rezum

Rezum

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Can-Am HIFU Inc.

OTHER

Sponsor Role lead

Responsible Party

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Dean Elterman

Urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dean Elterman

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Dean Elterman

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Iris Chan

Role: CONTACT

416-603-5800 ext. 5033

Dean Elterman

Role: CONTACT

141660358005033

Facility Contacts

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Dean Elterman

Role: primary

4166035800 ext. 5033

Iris Chan

Role: backup

4166035800 ext. Elterman

Other Identifiers

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Rezum in BPH CAN

Identifier Type: -

Identifier Source: org_study_id

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