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

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

Overview

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.

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 obstr

Primary outcome measures

• Primary Safety (Stage 1 and Stage 2) - Incidence and severity of procedural and device related adverse events. [Time frame: 12 Months]
• Primary Safety (Stage 2) - Incidence of post-operative catheterization after 7 days, up to 14 days. [Time frame: 2 weeks]
• Efficacy (Stage 2) - Change in urinary related symptom [Time frame: 3 Months]

Secondary outcome measures (12)

• Functionality (Stage 1) - Location and orientation of Omega implant in the prostate before prostatectomy is as planned: Yes/No [Time frame: Procedure day]
• Functionality (Stage 1) - Location and depth Omega incision in the excised prostate is as planned: Yes/No. [Time frame: Procedure day]
• Usability (Stage 1 and Stage 2) - Evaluate the usability of the device and entire process [Time frame: Procedure day]
• Efficacy (Stage 2) - Improvement in urinary related symptoms [Time frame: 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 [Time frame: 1 Months, 3 Months, 6 Months and 12 months]
• Exploratory - Change in PSA compared to baseline [Time frame: 1 Months, 6 Months and 12 Months]
• 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). [Time frame: 3 Months, 6 Months and 12 months]
• Exploratory - Change in VAS pain score [Time frame: Procedure day, 1-2 weeks and 1 month]
• Exploratory - Change in post-void residual (PVR) test [Time frame: 1 Months, 3 Months, 6 Months and 12 months]
• Exploratory - Incidence of inflammation, assessed by cystoscope [Time frame: 6 months]
• Exploratory - Omega coverage assessed by cystoscope [Time frame: 6 months]
• Exploratory - Change in the BPHII score from Baseline [Time frame: 1 Months, 3 Months, 6 Months and 12 months]

Eligibility criteria

Stage 1

Inclusion criteria

• 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

Exclusion criteria

• 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

Inclusion criteria

• Male ≥50 years old.
• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Georgia · 5 centers

• N(N)LE New Vision University Hospital — Tbilisi
• Israeli-Georgian Medical Research Clinic Healthycore — Tbilisi
• JSC L.Managadze National Center of Urology — Tbilisi
• Tbilisi Heart Center — Tbilisi
• Todua Clinic — Tbilisi

Identifiers

NCT: NCT05757687 · PA-CP-22

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗