Study of Median Lobe Prostatic UroLift Procedure
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2015
CompletedFirst Posted
Study publicly available on registry
December 9, 2015
CompletedStudy Start
First participant enrolled
February 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2017
CompletedResults Posted
Study results publicly available
February 26, 2019
CompletedFebruary 26, 2019
February 1, 2019
1.3 years
December 5, 2015
May 30, 2018
February 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%.
The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.
6 months
Secondary Outcomes (10)
Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up
12 Months
Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up
12 Months
Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up
12 Months
Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up
12 Months
Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up
12 Months
- +5 more secondary outcomes
Study Arms (1)
UroLift System procedure
EXPERIMENTALAll eligible,enrolled subjects will undergo a UroLift procedure
Interventions
Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Eligibility Criteria
You may qualify if:
- Enlarged median lobe (ML) contributing to obstruction of the prostate
- BPH
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeoTract, Inc.lead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emily Hergenreter, Sr. Director of Clinical Affairs
- Organization
- NeoTract/Teleflex
Study Officials
- PRINCIPAL INVESTIGATOR
Dan B. Rukstalis, M.D.
Wake Forest
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2015
First Posted
December 9, 2015
Study Start
February 17, 2016
Primary Completion
May 30, 2017
Study Completion
December 19, 2017
Last Updated
February 26, 2019
Results First Posted
February 26, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share