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

ProArc Medical5 sites in 1 country11 target enrollmentFebruary 7, 2023

ConditionsLower Urinary Tract Symptoms Benign Prostatic Hyperplasia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lower Urinary Tract Symptoms
Sponsor: ProArc Medical
Enrollment: 11
Locations: 5
Primary Endpoint: Primary Safety (Stage 2) - Incidence of post-operative catheterization after 7 days, up to 14 days.
Status: Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 7, 2023

End Date

September 1, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

ProArc Medical

Responsible Party

Sponsor

Eligibility Criteria

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) \>
•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.

Outcomes

Primary Outcomes

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

Time Frame: 2 weeks

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

Efficacy (Stage 2) - Change in urinary related symptom

Time Frame: 3 Months

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)

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

Time Frame: 12 Months

Incidence and severity of procedural and device related adverse events.

Secondary Outcomes

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