Study Results
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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RECRUITING
238 participants
OBSERVATIONAL
2025-06-30
2029-02-28
Brief Summary
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Detailed Description
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Enrolled subjects undergoing diagnostic or therapeutic procedures using study devices will be followed for 1 year after the index procedure is complete.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Urinary Tract Procedure Cohort
Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s)
Ureteroscope system
LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
Laser system
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Benign Prostatic Hyperplasia Cohort
Subjects are at least 40 years of age diagnosed with BPH with lower urinary tract symptoms and intend to undergo BPH treatment with study device(s)
Laser system
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Interventions
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Ureteroscope system
LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
Laser system
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Eligibility Criteria
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Inclusion Criteria
1. Subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)
2. Subject is willing and able to complete all follow-up visits
For BPH cohort:
1. Subject is ≥ 40 years of age
2. Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
3. Subject intends to undergo BPH treatment with qualified BSC device(s)
4. Subject is willing and able to complete all follow-up visits
Exclusion Criteria
1. Subject requires simultaneous surgical treatment for BPH
2. Unwilling or unable to provide consent
3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
For BPH cohort:
1. Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
2. Unwilling or unable to provide consent
3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gita Ghadimi, OD
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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University of Miami Hospital
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Curtis Blackwell
Role: CONTACT
Phone: 952-930-6000
Facility Contacts
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Elena Cortez
Role: primary
Ray De La Morena Quirch
Role: primary
Alexander Czachor
Role: backup
Stephanie Wofford
Role: primary
Rebecca Schmidt
Role: primary
Other Identifiers
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U0777
Identifier Type: -
Identifier Source: org_study_id