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NCT00465101 · ClinicalTrials.gov registry record · Phase 4
A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization
A Phase 4 study of Benign Prostatic Hyperplasia, sponsored by American Medical Systems.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 9
- Study locations
NCT00465101: Completed Phase 4 study of Benign Prostatic Hyperplasia, sponsored by American Medical Systems.
NCT00465101 is a Phase 4 study of Benign Prostatic Hyperplasia that has completed, run by American Medical Systems. The registered enrollment target is 150 participants, below the 547-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (73% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00465101, a Phase 4 study of Benign Prostatic Hyperplasia, has completed, sponsored by American Medical Systems.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 9
- Study locations
Study Summary
To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms.
Primary Outcome
Treatment success is determined on a per patient basis and is defined as \[(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS\] greater than or equal to 50%
Conditions Studied
Interventions
- DEVICE GreenLight HPS
Study Locations (9)
California
- UCLA - Los Angeles
Connecticut
- Connecticut Clinical Reseach Center - Middlebury
Georgia
- North Fulton Urology, P.C. - Roswell
Michigan
- Affiliates in Urology - Detroit
New York
- PC Group/Universtiy Urology Association - New York
Ohio
- Glickman Urological Institute - Cleveland
Oklahoma
- Oklahoma University Health Science Center_Urology - Oklahoma City
Texas
- UT Southwestern Medical Center at Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2007-05 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
What the finished NCT00465101 record still lists
NCT00465101 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 547-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 1 intervention - of which GreenLight HPS is the first listed.
NCT00465101 lists 9 locations in 9 states (California, Connecticut, Georgia).
Frequently Asked Questions
What is clinical trial NCT00465101 about?
NCT00465101 is a clinical study titled "A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization". To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms.
What is the current status of trial NCT00465101?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2007-05. Estimated completion is 2013-01.
What conditions does trial NCT00465101 study?
This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.
What interventions are being tested in trial NCT00465101?
The interventions under investigation include: GreenLight HPS (DEVICE).
Who is sponsoring clinical trial NCT00465101?
This trial is sponsored by American Medical Systems, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00465101 being conducted?
This trial has 9 study locations across California, Connecticut, Georgia, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00465101's enrollment target sits among peer trials
150 14th of 29 higher than 15 of 29 other Benign Prostatic Hyperplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Benign Prostatic Hyperplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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