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Tests treatment safety and results for Benign Prostatic Hyperplasia
Official title Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
ClinicalTrials.gov ID: NCT04627701
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- Male ≥50 years of age
- Diagnosed with symptomatic benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) \>13.
- Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
- Participant understands and is willing to the informed consent form.
You likely can't join if
- Concomitant participation in another treatment study.
- Unable to comply with the clinical protocol including all the follow-up requirements.
- Vulnerable population such as inmates or developmentally delayed individuals.
- Significant comorbidities which would affect study participation.
- Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
- Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as:
See the full eligibility criteria
- Male ≥50 years of age
- Diagnosed with symptomatic benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) \>13.
- Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
- Participant understands and is willing to the informed consent form.
- Prostate Volume between 30cc and 80cc.
- Prostate length ≥3cm and ≤5cm
- Concomitant participation in another treatment study.
- Unable to comply with the clinical protocol including all the follow-up requirements.
- Vulnerable population such as inmates or developmentally delayed individuals.
- Significant comorbidities which would affect study participation.
- Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
- Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as:
- Use of concomitant medications (e.g., anticholinergics, antispasmodics, or antidepressants) affecting bladder function.
- Patient with coagulopathy due to medications or congenital condition - inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the...
- Alpha-blockers within 2 weeks of pre-treatment (baseline) evaluation.
- Taking 5-alpha reductase inhibitors (5-ARI) within 6 months (3 months for type II 5-ARI) of pre-treatment (baseline) evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the...
- Patient is taking steroids. [Note: Patients approved for the trial who are using the above medications will continue using them after the trial, except for Alpha blockers]
- Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
- Compromised renal function due to obstructive uropathy.
- Active Urinary Tract Infection (UTI).
- Obstructive or protruding median lobe
- American Society of Anaesthesiologists score (ASA) \> 3.
- Known neurogenic bladder or neurological disorders that might affect bladder or function.
- Recent myocardial infarction (less than three months).
- Concomitant bladder stones.
- Current gross hematuria.
- Active or history of epididymitis within the past 3 months.
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
- Confirmed or suspected malignancy of bladder.
- History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms.
- Other Urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
- Bacterial prostatitis within the last 12 months.
- Previous rectal surgery, other than hemorrhoidectomy.
- Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%).
- Known allergy to nickel or titanium or stainless steel.
The study team makes the final eligibility decision.
Where it's taking place
- Beersheba, Israel
- Haifa, Israel
- Tauranga, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beersheba, Israel; Haifa, Israel; Tauranga, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.