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Lower Urinary Tract SymptomsOmegaNCT05757687

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

A study testing Omega device in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by ProArc Medical at 5 sites in Georgia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older, men only
What is being tested?
Omega device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
5 sitesGeorgia
Study dates
7 Feb 2023to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Male ≥50 years old.
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  • Suspected 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

Who cannot join

  • 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.
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  • 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
  • Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
  • 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.
  • 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.
  • American Society of Anesthesiologists score (ASA) > 3.
  • Known neurogenic bladder or neurological disorders that might affect bladder or function.
  • Recent myocardial infarction (less than three months).
  • Concomitant bladder stones.
  • Current gross hematuria.
  • Active or history of epididymitis within the past 3 months.
  • Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
  • Confirmed or suspected malignancy of bladder.
  • History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms.
  • Other urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
  • Bacterial prostatitis within the last 12 months.
  • Previous rectal surgery, other than hemorrhoidectomy.
  • Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%).
  • Known allergy to nickel or titanium or stainless steel.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Georgia5 sites

  • N(N)LE New Vision University Hospital

    Tbilisi, 0159

  • Israeli-Georgian Medical Research Clinic Healthycore

    Tbilisi

  • JSC L.Managadze National Center of Urology

    Tbilisi

  • Tbilisi Heart Center

    Tbilisi

  • Todua Clinic

    Tbilisi

Other trials in Georgia

About this study

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

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.

Being tested
Omega device
Medical subject headings
Lower Urinary Tract Symptoms, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega deviceDevice

    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.

Study groups in NCT05757687
Study groupRoleWhat they receive
Omega procedureExperimentalNot described
Receives: Device: Omega device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 Months

  2. 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.

    Measured: 2 weeks

  3. 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)

    Measured: 3 Months

Secondary outcomes (14)

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

    Evaluating whether the outcome of the Omega implant's location and orientation turned out as the surgeon planned prior to the Omega procedure.

    Measured: Procedure day

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

    Evaluating whether the Omega incision location and depth outcome turned out as the surgeon planned prior to the Omega procedure.

    Measured: Procedure day

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

    Evaluate the usability of the device and the entire process using the usability questionnaire (The highest score of 60 indicates that the device is extremely user-friendly, while the lowest score of 12 indicates that the device is very difficult to use)

    Measured: Procedure day

  4. Efficacy (Stage 2) - Improvement in urinary related symptoms

    Evaluate the improvement in urinary-related symptoms as evidenced by a decrease of at least 30% in the IPSS score. (A score of 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms and 20-35 indicates severe symptoms)

    Measured: 1 Months, 6 Months and 12 months

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

    Measured: 1 Months, 3 Months, 6 Months and 12 months

  6. Exploratory - Change in PSA compared to baseline

    Measured: 1 Months, 6 Months and 12 Months

  7. Exploratory - Change in sexual function assessments from screening to 3, 6 and 12 months using the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire for Ejaculatory Function (MSHQ-EjD).

    The IIEF-15 score ranges from 6 to 75 and is used to classify erectile dysfunction (ED).

    An MSHQ-EjD score of 20 indicates the absence of ejaculatory dysfunction, while a score of 0 indicates a high level of ejaculatory dysfunction.

    Measured: 3 Months, 6 Months and 12 months

  8. Exploratory - Change in VAS pain score

    A VAS pain score of (0-1 mm) indicates no pain,(2-4 mm) - mild pain, (4-7 mm) - moderate pain, and (7-10 mm) - severe pain.

    Measured: Procedure day, 1-2 weeks and 1 month

  9. Exploratory - Change in post-void residual (PVR) test

    Measured: 1 Months, 3 Months, 6 Months and 12 months

  10. Exploratory - Incidence of inflammation, assessed by cystoscope

    Measured: 6 months

  11. Exploratory - Omega coverage assessed by cystoscope

    Measured: 6 months

  12. Exploratory - Change in the BPHII score from Baseline

    Measured: 1 Months, 3 Months, 6 Months and 12 months

  13. Incidence of repeat invasive treatment for Lower Urinary Tract Symptoms (LUTS) or increase in dosage or initiation of new medication to treat symptoms of BPH

    Measured: 12 months

  14. Incidence of Device removal

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2023
  2. Study start7 Feb 2023
  3. Primary completion30 Apr 2026
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05757687
Sponsor's protocol ID
PA-CP-22
Acronym
Omega
Status last verified
Sep 2026
First submitted
15 Feb 2023
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Omega device in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by ProArc Medical at 5 sites in Georgia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety (Stage 1 and Stage 2) - Incidence and severity of procedural and device related adverse events. (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05757687.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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