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

NCT05757687 | Recruiting

• 1 other identifier: PA-CP-22
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 5

Brief Summary

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

Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (3)

• Primary Safety (Stage 1 and Stage 2) - Incidence and severity of procedural and device related adverse events.

  Incidence and severity of procedural and device related adverse events.

  12 Months

• Primary Safety (Stage 2) - Incidence of post-operative catheterization after 7 days, up to 14 days.

  Incidence of post-operative catheterization after 7 days, up to 14 days.

  2 weeks

• Efficacy (Stage 2) - Change in urinary related symptom

  Improvement in urinary related symptoms as evidenced by at least 30% decrease in International Prostate Symptom Score (A score of 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms and 20-35 indicates severe symptoms)

  3 Months

Secondary Outcomes (14)

• Functionality (Stage 1) - Location and orientation of Omega implant in the prostate before prostatectomy is as planned: Yes/No

  Procedure day

• Functionality (Stage 1) - Location and depth Omega incision in the excised prostate is as planned: Yes/No.

  Procedure day

• Usability (Stage 1 and Stage 2) - Evaluate the usability of the device and entire process

  Procedure day

• Efficacy (Stage 2) - Improvement in urinary related symptoms

  1 Months, 6 Months and 12 months

• Efficacy (Stage 2) - Improvement of peak urinary flow rate as evidenced by an increase of at least 25% in uroflowmetry Qmax

  1 Months, 3 Months, 6 Months and 12 months

Study Arms (1)

Omega procedure

EXPERIMENTAL

Device: Omega device

Interventions

Omega device DEVICE

The ProArc Medical Omega system is a prostatic reshaping device. The Omega System is comprised of two main components: Omega Delivery Device and Omega Implant. The delivery system uses a diathermy electrode to perform a circular and superficial incision through the urethral wall into the prostate tissue, into which the arc-shaped permanent implant is placed. The implant is made up of commonly used surgical implantable nitinol material, coated with Parylene coating. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.

Omega procedure

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 and ≤ 80 years old.
• Will undergo planned prostatectomy.
• Participant understands and is willing to the informed consent form.
• Prostate Volume between 30cc and 80cc.
• Prostate length ≥ 3cm

You may not qualify if:

• Unable to comply with the clinical protocol.
• Vulnerable population such as inmates or developmentally delayed individuals.
• Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as:
• 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 is not prohibited).
• Use of alpha-blockers within 2 weeks of pre-treatment (baseline) evaluation.
• Use of 5-α-reductase inhibitors within 6 months of pre-treatment (baseline) evaluation.
• American Society of Anesthesiologists score (ASA) \> 3.
• Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
• Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
• Other urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
• Previous rectal surgery, other than hemorrhoidectomy
• Current gross hematuria.
• Known allergy to nickel or titanium or stainless steel.
• Stage 2
• Male ≥50 years old.

Sponsors & Collaborators

• ProArc Medical: lead

Study Sites (5)

N(N)LE New Vision University Hospital

Tbilisi, 0159, Georgia

RECRUITING

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia

RECRUITING

JSC L.Managadze National Center of Urology

Tbilisi, Georgia

RECRUITING

Tbilisi Heart Center

Tbilisi, Georgia

RECRUITING

Todua Clinic

Tbilisi, Georgia

TERMINATED

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Frank Mastandrea, Dr

  Board Member and Medical Director

  STUDY DIRECTOR

Central Study Contacts

Fay Dan

CONTACT

972-544-781-599; fay@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: February 15, 2023
• First Posted: March 7, 2023
• Study Start: February 7, 2023
• Primary Completion: January 3, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GE (5)