To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
NCT ID: NCT02962674
Last Updated: 2021-10-15
Study Results
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View full resultsBasic Information
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TERMINATED
NA
49 participants
INTERVENTIONAL
2016-09-19
2020-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
prostaFix System
Interventions
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prostaFix System
Eligibility Criteria
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Inclusion Criteria
* International Prostate Symptom Score (IPSS) of 12 or greater,
* Prostate volume between 25 cm3 and 55 cm3,
* Uroflow with peak flow rate (Qmax) no greater than 13 ml/sec with a corresponding voided volume of at least 100 ml and a post void residual (PVR) of 250 ml or less.
* Prostate length, width and height must be at least 3.2 cm, 3.5 cm and 2.5 cm, respectively
Exclusion Criteria
* Subjects on 5 alpha reductase inhibitors (5-ARI) (inclusion only if washed out prior to treatment),
* Subjects on alpha blockers (inclusion only if washed-out before treatment),
* Active urinary tract infection at time of treatment,
* Interest in maintaining fertility,
* Past history of urologic surgery or minimally invasive treatment for BPH,
* History of or current medical conditions contraindicating elective urological procedures.
45 Years
MALE
No
Sponsors
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ProstaCare Singapore Pte. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Henry Ho Sun Sien, MD
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
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Urology Bay of Plenty (BOP)
Tauranga, , New Zealand
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CIP# PC 1.0
Identifier Type: -
Identifier Source: org_study_id