Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
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.
Interventions
DEVICEOmega 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
ProArc Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage 1 Inclusion Criteria: 1. Male ≥50 years of age and ≤ 80 years old. 2. Will undergo planned prostatectomy. 3. Participant understands and is willing to the informed consent form. 4. Prostate Volume between 30cc and 80cc. 5. Prostate length ≥ 3cm
Exclusion criteria
1. Unable to comply with the clinical protocol. 2. Vulnerable population such as inmates or developmentally delayed individuals. 3. 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. 4. American Society of Anesthesiologists score (ASA) \> 3. 5. Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate. 6. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate. 7. Other urethral conditions that may prevent insertion of Delivery Device into prostatic urethra. 8. Previous rectal surgery, other than hemorrhoidectomy 9. Current gross hematuria. 10. Known allergy to nickel or titanium or stainless steel. Stage 2 Inclusion Criteria: 1. Male ≥50 years old. 2. Suspected symptomatic benign prostatic hyperplasia (BPH). 3. International Prostate Symptom Score (IPSS) \>13. 4. Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml). 5. Participant understands and is willing to the informed consent form. 6. Prostate Volume between 30cc and 80cc. 7. Prostate length ≥ 3cm and ≤ 5cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety (Stage 1 and Stage 2) - Incidence and severity of procedural and device related adverse events. | 12 Months | Incidence and severity of procedural and device related adverse events. |
| Primary Safety (Stage 2) - Incidence of post-operative catheterization after 7 days, up to 14 days. | 2 weeks | Incidence of post-operative catheterization after 7 days, up to 14 days. |
| Efficacy (Stage 2) - Change in urinary related symptom | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functionality (Stage 1) - Location and depth Omega incision in the excised prostate is as planned: Yes/No. | Procedure day | Evaluating whether the Omega incision location and depth outcome turned out as the surgeon planned prior to the Omega procedure. |
| Usability (Stage 1 and Stage 2) - Evaluate the usability of the device and entire process | Procedure day | 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) |
| Efficacy (Stage 2) - Improvement in urinary related symptoms | 1 Months, 6 Months and 12 months | 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) |
| 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 PSA compared to baseline | 1 Months, 6 Months and 12 Months | — |
| Exploratory - Change in post-void residual (PVR) test | 1 Months, 3 Months, 6 Months and 12 months | — |
| Exploratory - Incidence of inflammation, assessed by cystoscope | 6 months | — |
| Exploratory - Omega coverage assessed by cystoscope | 6 months | — |
| Exploratory - Change in the BPHII score from Baseline | 1 Months, 3 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 | — |
| Incidence of Device removal | 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 | 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. |
| Exploratory - Change in VAS pain score | Procedure day, 1-2 weeks and 1 month | 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. |
| Functionality (Stage 1) - Location and orientation of Omega implant in the prostate before prostatectomy is as planned: Yes/No | Procedure day | Evaluating whether the outcome of the Omega implant's location and orientation turned out as the surgeon planned prior to the Omega procedure. |
Countries
Georgia
Contacts
Primary ContactFay Dan
Outcome results
None listed