Study Results
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View full resultsBasic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2016-02-17
2017-12-19
Brief Summary
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Detailed Description
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Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study.
Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UroLift System procedure
All eligible,enrolled subjects will undergo a UroLift procedure
UroLift System procedure
Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Interventions
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UroLift System procedure
Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BPH
Exclusion Criteria
50 Years
MALE
No
Sponsors
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NeoTract, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dan B. Rukstalis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wake Forest
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP00001
Identifier Type: -
Identifier Source: org_study_id
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