Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

NCT ID: NCT05567666

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-12-31

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Optilume Catheter System

Group Type: EXPERIMENTAL

Optilume Catheter System

Intervention Type: DEVICE

Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter

Interventions

Optilume Catheter System

Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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

3. Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria

1. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements

2. 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

3. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate

4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate

5. Confirmed or suspected malignancy of prostate or bladder

6. Active urinary tract infection (UTI) confirmed by culture

7. History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable

8. 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.)

9. History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage)

10. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

11. Significant obstruction from median lobe in the opinion of the investigator

12. Disease or other health condition that is not suitable for this study

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Urotronic Inc.

INDUSTRY

Sponsor Role: collaborator

Dean Elterman

OTHER

Sponsor Role: lead

Responsible Party

Dean Elterman

Lead Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Iris Chan

Role: CONTACT

iris.chan2@uhn.ca

416-603-5800 ext. 5033

Dean Elterman

Role: CONTACT

dean.elterman@uhn.ca

Other Identifiers

SUMMIT (Protocol no.: 1001)

Identifier Type: -

Identifier Source: org_study_id