NCT05567666

Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

A Real-word, Clinical Study to Evaluate the Performance of the Optilume® BPH Catheter System in Men With Symptomatic Benign Prostatic Hyperplasia (BPH)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Dean Elterman · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

A post-marketing study using Optilume Catheter System for benign prostatic hyperplasia.

Detailed description

This is a post-marketing study for using Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter, to treat benign prostatic hyperplasia. Participants will go through screening process which include uroflow test (measure the strength of urine flow), post-void residual volume by bladder scan, questionnaires and transrectal ultrasound (TRUS) to determine the eligibility to the study. Participants will be followed up for 1 year after Optilume treatment procedure.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Optilume Catheter System	Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-10-05
• Last updated: 2022-10-05

Regulatory

• FDA-regulated device study