Clinical trial NCT05757687: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Lead sponsor: ProArc Medical
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 11
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Exclusion Criteria:

1. Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
2. Concomitant participation in another interventional study.
3. Unable to comply with the clinical protocol including all the follow-up requirements.
4. Vulnerable population such as inmates or developmentally delayed individuals.
5. Significant comorbidities which would affect study participation.
6. 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. \[Note: Patients approved for the trial who are using the above medications will continue using them after the trial, except for Alpha blockers.\]
7. Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
8. Compromised renal function due to obstructive uropathy.
9. Active Urinary Tract Infection (UTI).
10. Obstructive or protruding median lobe.
11. American Society of Anesthesiologists score (ASA) \> 3.
12. Known neurogenic bladder or neurological disorders that might affect bladder or function.
13. Recent myocardial infarction (less than three months).
14. Concomitant bladder stones.
15. Current gross hematuria.
16. Active or history of epididymitis within the past 3 months.
17. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
18. Confirmed or suspected malignancy of bladder.
19. History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms.
20. Other urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
21. Bacterial prostatitis within the last 12 months.
22. Previous rectal surgery, other than hemorrhoidectomy.
23. Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%).
24. Known allergy to nickel or titanium or stainless steel.

Primary outcomes:
measure: Primary Safety (Stage 1 and Stage 2) - Incidence and severity of procedural and device related adverse events.
timeFrame: 12 Months
measure: Primary Safety (Stage 2) - Incidence of post-operative catheterization after 7 days, up to 14 days.
timeFrame: 2 weeks
measure: Efficacy (Stage 2) - Change in urinary related symptom
timeFrame: 3 Months
Secondary outcomes:
measure: Functionality (Stage 1) - Location and orientation of Omega implant in the prostate before prostatectomy is as planned: Yes/No
timeFrame: Procedure day
measure: Functionality (Stage 1) - Location and depth Omega incision in the excised prostate is as planned: Yes/No.
timeFrame: Procedure day
measure: Usability (Stage 1 and Stage 2) - Evaluate the usability of the device and entire process
timeFrame: Procedure day
measure: Efficacy (Stage 2) - Improvement in urinary related symptoms
timeFrame: 1 Months, 6 Months and 12 months
measure: Efficacy (Stage 2) - Improvement of peak urinary flow rate as evidenced by an increase of at least 25% in uroflowmetry Qmax
timeFrame: 1 Months, 3 Months, 6 Months and 12 months
measure: Exploratory - Change in PSA compared to baseline
timeFrame: 1 Months, 6 Months and 12 Months
measure: 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).
timeFrame: 3 Months, 6 Months and 12 months
measure: Exploratory - Change in VAS pain score
timeFrame: Procedure day, 1-2 weeks and 1 month
measure: Exploratory - Change in post-void residual (PVR) test
timeFrame: 1 Months, 3 Months, 6 Months and 12 months
measure: Exploratory - Incidence of inflammation, assessed by cystoscope
timeFrame: 6 months
measure: Exploratory - Omega coverage assessed by cystoscope
timeFrame: 6 months
measure: Exploratory - Change in the BPHII score from Baseline
timeFrame: 1 Months, 3 Months, 6 Months and 12 months
measure: 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
timeFrame: 12 months
measure: Incidence of Device removal
timeFrame: 12 months
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: N(N)LE New Vision University Hospital
city: Tbilisi
country: Georgia
facility: JSC L.Managadze National Center of Urology
city: Tbilisi
country: Georgia
facility: Todua Clinic
Study officials:
affiliation: Board Member and Medical Director
name: Frank Mastandrea, Dr
role: STUDY_DIRECTOR
References: