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

NCT05757687 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-08-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ProArc Medical

    lead INDUSTRY

Principal Investigators

  • Frank Mastandrea, Dr · Board Member and Medical Director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2026-01-03
Completion
2026-09-01

Countries

  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757687 on ClinicalTrials.gov