Post-Market Study to Assess iTind Safety in Comparison to UroLift
NCT04757116 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206
Last updated 2026-05-06
Summary
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
Conditions
- Benign Prostatic Hyperplasia (BPH)
Interventions
- DEVICE
-
iTind
The iTind is implemented for 5-7 days
- PROCEDURE
-
UroLift
UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.
Sponsors & Collaborators
-
Olympus Europe SE & Co. KG
collaborator INDUSTRY -
Olympus Corporation of the Americas
lead INDUSTRY
Principal Investigators
-
Bilal Chughtai, MD · Northwell Health
-
Neil Barber, MD · Frimley Park Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-26
- Primary Completion
- 2026-06-30
- Completion
- 2031-12-31
- FDA Device
- Yes
Countries
- United States
- United Kingdom
Study Locations
More Related Trials
-
Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia
NCT01436877 ·Status: COMPLETED ·Phase: NA
-
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
NCT06312722 ·Status: RECRUITING ·Phase: NA
-
Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
NCT00435448 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
NCT01967251 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of Light-Activated Talaporfin Sodium in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
NCT00918034 ·Status: COMPLETED ·Phase: PHASE2
-
Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath
NCT05400980 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS).
NCT02431754 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Median Lobe Prostatic UroLift Procedure
NCT02625545 ·Status: COMPLETED ·Phase: NA
-
Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men
NCT03043222 ·Status: WITHDRAWN ·Phase: NA
-
Real World Data on Management of Male LUTS
NCT03075449 ·Status: COMPLETED
-
IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation
NCT06157164 ·Status: TERMINATED
-
Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia
NCT02592473 ·Status: UNKNOWN ·Phase: NA
-
Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH
NCT04987892 ·Status: RECRUITING ·Phase: PHASE4
-
A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease
NCT01685437 ·Status: COMPLETED ·Phase: PHASE3
-
MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
NCT03131544 ·Status: COMPLETED ·Phase: NA
-
Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
NCT00237536 ·Status: TERMINATED ·Phase: PHASE2
-
The Safety and Effectiveness of UroLift: LIFT Pivotal Study
NCT01294150 ·Status: COMPLETED ·Phase: NA
-
Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms
NCT02252367 ·Status: COMPLETED ·Phase: PHASE4
-
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
NCT06849258 ·Status: RECRUITING ·Phase: NA
-
Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome
NCT03543761 ·Status: COMPLETED ·Phase: NA
-
Botulinum Toxin Injection for the Management of BPH
NCT00451191 ·Status: COMPLETED ·Phase: PHASE2
-
Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction
NCT00147654 ·Status: COMPLETED ·Phase: PHASE4
-
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
NCT04103450 ·Status: COMPLETED ·Phase: PHASE3
-
Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
NCT04245566 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Optilume™ BPH Catheter System in Men With Symptomatic BPH
NCT04131907 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA