Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT05567666
Status:
UNKNOWN
Last Update Posted:
2022-10-05
First Post:
2022-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)
Sponsor:
Dean Elterman
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUMMIT
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: