NCT01876706

Brief Summary

The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 25, 2015

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2018

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

May 6, 2013

Results QC Date

April 29, 2015

Last Update Submit

March 18, 2019

Conditions

Benign Prostatic Hyperplasia

Keywords

UroLift System

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery

    Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.

    1 Month

Secondary Outcomes (13)

  • IPSS Scores at Baseline and 12 Month Follow-up

    12 Months

  • IPSS 12 Month Change From Baseline

    12 Months

  • IPSS 12 Month Percent (%) Change From Baseline

    12 Months

  • BPH II Scores at Baseline and 12 Month Follow-up

    12 Month

  • BPH II 12 Month Percent (%) Change From Baseline

    12 Months

  • +8 more secondary outcomes

Study Arms (1)

UroLift® System

EXPERIMENTAL

Single-arm of qualified subjects receiving UroLift® System intervention.

Device: UroLift® System

Interventions

UroLift® SystemDEVICE

The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.

UroLift® System

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

You may not qualify if:

  • Size, volume,length of prostate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Genesis Research LLC

San Diego, California, 92123, United States

Location

Advanced Urology Institute

Daytona Beach, Florida, 32114, United States

Location

Pinellas Urology

St. Petersburg, Florida, 33710, United States

Location

Chesapeake Urology

Baltimore, Maryland, 21237, United States

Location

Sheldon J. Freedman, M.D., Ltd.

Las Vegas, Nevada, 89144, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Monica Ransom Director of Clinical Operations
Organization
NeoTract
Monica.Ransom@Teleflex.com
4159648770

Study Officials

  • Neal D Shore, MD

    Grand Strand Urology

    PRINCIPAL INVESTIGATOR

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

May 6, 2013

First Posted

June 13, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

September 4, 2018

Last Updated

March 20, 2019

Results First Posted

November 25, 2015

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(7)