NCT05757687

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

Evaluation of the Safety, Tolerability and Efficacy the Omega System for the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (estimated)
• Sponsor: ProArc Medical · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Omega 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.

Timeline

• Start date: 2023-02-07
• Primary completion: 2026-01-03
• Completion: 2026-09-01
• First posted: 2023-03-07
• Last updated: 2025-08-07

Locations

5 sites across 1 country: Georgia