Actively Recruiting
Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
Led by ProArc Medical · Updated on 2025-08-07
26
Participants Needed
4
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.
CONDITIONS
Official Title
Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male 50 years of age or older
- Diagnosed with symptomatic benign prostatic hyperplasia (BPH)
- International Prostate Symptom Score (IPSS) greater than 13
- Peak flow rate 12 ml/sec or less with voided volume of at least 125 ml
- Able to understand and willing to sign the informed consent form
- Prostate volume between 30 cc and 80 cc
- Prostate length between 3 cm and 5 cm
You will not qualify if you...
- Participation in another interventional study
- Unable to comply with the study protocol and follow-up requirements
- Vulnerable populations such as inmates or developmentally delayed individuals
- Significant other medical conditions affecting study participation
- Diagnosed or suspected prostate cancer (must be ruled out if suspected)
- Use of medications affecting bladder function (e.g., anticholinergics, antispasmodics, antidepressants)
- Coagulopathy or inability to stop anticoagulants/antiplatelets as required before the procedure
- Use of alpha-blockers within 2 weeks before baseline evaluation
- Use of 5-alpha reductase inhibitors within 6 months before baseline evaluation unless stable dose for 6 months
- Current use of steroids
- Previous prostate surgeries or invasive prostate treatments
- Compromised kidney function due to obstructive uropathy
- Active urinary tract infection
- Obstructive or protruding median lobe
- American Society of Anaesthesiologists score greater than 3
- Known neurogenic bladder or neurological disorders affecting bladder function
- Recent heart attack within the last 3 months
- Bladder stones
- Current visible blood in urine
- Recent epididymitis within 3 months
- Presence of artificial urinary sphincter or stents in urethra or prostate
- Confirmed or suspected bladder cancer
- History or presence of urethral strictures, bladder neck contracture, or bladder muscle spasms
- Other urethral conditions preventing delivery device insertion
- Bacterial prostatitis within the last 12 months
- Previous rectal surgery other than hemorrhoidectomy
- Uncontrolled diabetes with hemoglobin A1c 9% or higher
- Known allergy to nickel, titanium, or stainless steel
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Trial Site Locations
Total: 4 locations
1
Soroka Medical Center
Beersheba, Israel
Terminated
2
Carmel Medical Center
Haifa, Israel
Terminated
3
Rambam Health Care Campus
Haifa, Israel
Terminated
4
Tauranga Urology Research Limited
Tauranga, New Zealand
Actively Recruiting
Research Team
F
Fay Dan
CONTACT
G
Gilad Hizkiyahu
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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