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Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
N/A
Waitlist Available
Led By Bilal Chughtai, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing Urolift, a procedure that uses small implants to keep the urinary passage open, on patients who have urinary issues after radiation therapy. The implants help urine flow more easily by holding the passage open, which may reduce symptoms like frequent or painful urination. The UroLift® System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH), which opens the urethra by retracting obstructing prostatic lobes without incisions or thermal injury.
Eligible Conditions
- Enlarged Prostate
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and one year post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and one year post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in IIEF score through study completion, an average of 1 year
Change in IPSS scores from baseline and one year post treatment
Change in MSHQ through study completion, an average of 1 year
+3 moreSecondary study objectives
Change in medication usage through study completion, an average of 1 year
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: UroliftExperimental Treatment1 Intervention
This is a single-arm study involving 1 year of follow-up. Study intervention involves a one-time administration of Urolift prior to SBRT for prostate cancer treatment.
Find a Location
Who is running the clinical trial?
NeoTract, Inc.Industry Sponsor
10 Previous Clinical Trials
3,380 Total Patients Enrolled
TeleflexIndustry Sponsor
23 Previous Clinical Trials
7,404 Total Patients Enrolled
Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,114 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,725 Total Patients Enrolled
Bilal Chughtai, MDPrincipal InvestigatorNorthwell Health
5 Previous Clinical Trials
363 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are eligible for a Urolift surgery.You have been diagnosed with an enlarged prostate gland (BPH).
Research Study Groups:
This trial has the following groups:- Group 1: Urolift
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.