Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

NCT04627701 | Recruiting

• 1 other identifier: PA-CP-20
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Improvement in urinary related symptoms as evidenced by IPSS score

  3 months

Study Arms (1)

Omega Device

EXPERIMENTAL

Device: Omega

Interventions

Omega DEVICE

Omega Implantation

Omega Device

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• Prostate Volume between 30cc and 80cc.
• Prostate length ≥3cm and ≤5cm

You may not qualify if:

• Concomitant participation in another interventional 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 procedure; low dose aspirin therapy not prohibited.
• 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 drug dose should not be altered or discontinued throughout the study).
• 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

Sponsors & Collaborators

• ProArc Medical: lead

Study Sites (4)

Soroka Medical Center

Beersheba, Israel

TERMINATED

Carmel Medical Center

Haifa, Israel

TERMINATED

Rambam Health Care Campus

Haifa, Israel

TERMINATED

Tauranga Urology Research Limited

Tauranga, New Zealand

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fay Dan

CONTACT

+972 54-478-1599; Fay@proarcmedical.com

Gilad Hizkiyahu

CONTACT

+972 52-241-5544; gilad@proarcmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 13, 2020
• Study Start: July 23, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3); NZ (1)