Optilume BPH Catheter System in Benign Prostatic Hyperpla... | NCT05567666

Studies
Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

NCT05567666

Sponsor

Dean Elterman

Status

Unknown status

Last Update Posted

Oct 5, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Benign Prostatic Hyperplasia

Interventions

Optilume Catheter System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2022Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 29, 2022

First Submission Date that Met QC Criteria

Sep 30, 2022

First Posted Date

Oct 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2022

Last Update Posted Date

Oct 5, 2022Actual

Name	Class
Urotronic Inc.	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Treatment	Experimental	Optilume Catheter System	Device: Optilume Catheter System

Name	Type	Description	Arm Group Labels	Other Names
Optilume Catheter System	Device	Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy: Responder Rate at 12 months	≥30% improvement in International Prostate Symptom Score (IPSS) score without the need of an additional surgical or minimally invasive procedure. IPSS score ranges from 0-35 (higher score means worse symptoms)	12 months post treatment
Safety (adverse events)	Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.	Within 12 months post treatment

Secondary Outcomes

Measure	Description	Time Frame
Change in IPSS & IPSS QoL (questionnaire)	IPSS & IPSS QoL questionnaire	12 months post treatment
Change in Qmax (maximum flow rate)	Uroflow to measure maximum flow rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male subject with symptomatic BPH NOTE: Symptomatic BPH is defined as an International Prostate Symptom Score (IPSS) ≥ 13 and peak urinary flow rate (Qmax) of ≤15 mL/sec
Prostate dimensions suitable for treatment with the Optilume BPH Catheter System in accordance with the approved Instructions for Use NOTE: Prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by TRUS
Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria:

Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and a highly effective contraceptive for at least 6 months post-procedure
Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
Confirmed or suspected malignancy of prostate or bladder
Active urinary tract infection (UTI) confirmed by culture
History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)
History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage)
Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
Significant obstruction from median lobe in the opinion of the investigator
Disease or other health condition that is not suitable for this study

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Iris Chan	Contact	416-603-5800	5033	iris.chan2@uhn.ca
Dean Elterman	Contact			dean.elterman@uhn.ca

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases