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RECRUITINGNA

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

Evaluation of the Safety and Efficacy of the Omega System for the Treatment of Benign Prostatic Hyperplasia

NCT04627701•ProArc Medical

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.

Eligibility

Age

50 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Male ≥50 years of age
•2. Diagnosed with symptomatic benign prostatic hyperplasia (BPH).
•3. International Prostate Symptom Score (IPSS) \>13.
•4. Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
•5. Participant understands and is willing to the informed consent form.
•6. Prostate Volume between 30cc and 80cc.
•7. Prostate length ≥3cm and ≤5cm

Exclusion Criteria

•1. Concomitant participation in another interventional study.
•2. Unable to comply with the clinical protocol including all the follow-up requirements.
•3. Vulnerable population such as inmates or developmentally delayed individuals.
•4. Significant comorbidities which would affect study participation.
•5. Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
•6. 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).
+19 more criteria

Locations (4)

Soroka Medical Center

Beersheba, Israel

Carmel Medical Center

Haifa, Israel

Rambam Health Care Campus

Haifa, Israel

Tauranga Urology Research Limited

Tauranga, New Zealand

Key Dates

Start Date

July 23, 2023

Primary Completion Date

January 1, 2026

Completion Date

August 1, 2026

Last Updated

August 7, 2025

Enrollment

ESTIMATED participants

Conditions

Benign Prostatic HyperplasiaLower Urinary Tract Symptoms

Interventions

Omega

DEVICE

Contacts

Fay Dan

CONTACT

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

Gilad Hizkiyahu

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

RCT on Running Water Sound During Urodynamic

Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

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