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Clinical Trials/NCT05757687
NCT05757687RecruitingNot Applicable

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

ProArc Medical7 sites in 1 country11 target enrollmentStarted: February 7, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
11
Locations
7
Primary Endpoint
Primary Safety (Stage 2) - Incidence of post-operative catheterization after 7 days, up to 14 days.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion 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.
  • •Previous rectal surgery, other than hemorrhoidectomy
  • •Current gross hematuria.
  • •Known allergy to nickel or titanium or stainless steel.
  • •Inclusion Criteria:
  • •Male ≥50 years old.
  • •Suspected symptomatic benign prostatic hyperplasia (BPH).
  • •International Prostate Symptom Score (IPSS) >
  • •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) >
  • •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%).
  • +1 more not shown

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)

Investigators

Sponsor
ProArc Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (7)

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