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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02962674




Registration number
NCT02962674
Ethics application status
Date submitted
9/11/2016
Date registered
11/11/2016
Date last updated
31/08/2018

Titles & IDs
Public title
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
Scientific title
ProstaCare Water Electrolysis System for the Treatment of Benign Prostatic Hyperplasia
Secondary ID [1] 0 0
CIP# PC 1.0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ProstaCare System

Other: Treatment -


Treatment: Devices: ProstaCare System


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Device-related SAE
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Improvement in BPH Symptoms
Timepoint [2] 0 0
3 months

Eligibility
Key inclusion criteria
Key

- Enrolled subjects must be at least 45 years of age, diagnosed with BPH requiring
intervention.

- Subject must have symptoms and uroflowmetry results characteristic of BPH.

- Prostate must be of sufficient size to accommodate study device.

Key
Minimum age
45 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Urethral morphology unable to accommodate study device.

- Active urinary tract infection.

- Interest in maintaining fertility.

- Past history of surgical intervention for BPH.

- History or current medical conditions contraindicating elective urological procedures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Tauranga
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ProstaCare Singapore Pte. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and performance of the ProstaCare System
in relieving symptoms of urinary outflow obstruction secondary to benign prostatic
hyperplasia.
Trial website
https://clinicaltrials.gov/show/NCT02962674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Ho Sun Sien, MD
Address 0 0
Singapore General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications