Actively Recruiting

Phase Not Applicable
Age: 50Years +
MALE
NCT05757687

Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH

Led by ProArc Medical · Updated on 2025-08-07

11

Participants Needed

5

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, two-stage, multi-center, pilot clinical study to evaluate the safety/tolerability/efficacy of the Omega System device. The Omega arc-shaped implant is inserted by the Omega delivery system into the prostate tissue of subjects to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). The study will first evaluate the Omega system on patients undergoing prostatectomy, which is not indicated for the device.

CONDITIONS

Official Title

Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH

Who Can Participate

Age: 50Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 50 to 80 years for Stage 1; male aged 50 years or older for Stage 2
  • Planned prostatectomy for Stage 1 participants
  • Suspected symptomatic benign prostatic hyperplasia with International Prostate Symptom Score greater than 13 for Stage 2
  • Peak flow rate 12 ml/sec or less with voided volume of at least 125 ml for Stage 2
  • Prostate volume between 30cc and 80cc
  • Prostate length at least 3 cm for Stage 1; between 3 cm and 5 cm for Stage 2
  • Participant understands and is willing to sign informed consent form
Not Eligible

You will not qualify if you...

  • Unable to comply with clinical protocol or follow-up requirements
  • Vulnerable populations such as inmates or developmentally delayed individuals
  • Medical conditions or treatments interfering with the procedure, including inability to stop certain anticoagulants or antiplatelets as required
  • Use of alpha-blockers within 2 weeks before baseline evaluation
  • Use of 5-alpha reductase inhibitors within 6 months before baseline unless stable dose and voiding pattern
  • American Society of Anesthesiologists score greater than 3
  • Previous prostate surgery such as TURP, stent implantation, laser prostatectomy, hyperthermia, or other invasive treatment
  • Presence of artificial urinary sphincter or stents in urethra or prostate
  • Other urethral conditions preventing device insertion
  • Previous rectal surgery other than hemorrhoidectomy
  • Current gross hematuria
  • Known allergy to nickel, titanium, or stainless steel
  • Diagnosed or suspected prostate cancer unless ruled out (Stage 2)
  • Significant comorbidities affecting study participation (Stage 2)
  • Use of medications affecting bladder function such as anticholinergics, antispasmodics, or antidepressants (Stage 2)
  • Compromised renal function due to obstructive uropathy (Stage 2)
  • Active urinary tract infection (Stage 2)
  • Obstructive or protruding median lobe (Stage 2)
  • Known neurogenic bladder or neurological disorders affecting bladder function (Stage 2)
  • Recent myocardial infarction within 3 months (Stage 2)
  • Concomitant bladder stones (Stage 2)
  • Active or recent epididymitis within 3 months (Stage 2)
  • Confirmed or suspected bladder malignancy (Stage 2)
  • History or presence of strictures in anterior urethra, bladder neck contracture, or detrusor muscle spasms (Stage 2)
  • Bacterial prostatitis within last 12 months (Stage 2)
  • Current uncontrolled diabetes with hemoglobin A1c 9% or higher (Stage 2)
  • Patient taking steroids (Stage 2)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

N(N)LE New Vision University Hospital

Tbilisi, Georgia, 0159

Actively Recruiting

2

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

Actively Recruiting

3

JSC L.Managadze National Center of Urology

Tbilisi, Georgia

Actively Recruiting

4

Tbilisi Heart Center

Tbilisi, Georgia

Actively Recruiting

5

Todua Clinic

Tbilisi, Georgia

Terminated

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Research Team

F

Fay Dan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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