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

Primary Purpose

Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Status
Recruiting
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Omega device
Sponsored by
ProArc Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 of age and ≤ 80 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-α-reductase inhibitors within 6 months of pre-treatment (baseline) evaluation. 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 and 5-α-reductase.] 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). Intravesical lobe (if approved by prior cystoscopy). Obstructive 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. Diagnosed with Chronic Pelvic Pain Syndrome (CPPS). Previous rectal surgery, other than hemorrhoidectomy. Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%). Known allergy to nickel or titanium or stainless steel.

Sites / Locations

  • JSC L.Managadze National Center of UrologyRecruiting
  • Todua ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega procedure

Arm Description

Outcomes

Primary Outcome Measures

Primary Safety (Stage 1 and Stage 2) - Incidence and severity of procedural and device related adverse events.
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.
Incidence of post-operative catheterization after 7 days, up to 14 days.
Efficacy (Stage 2) - Change in urinary related symptom
Improvement in urinary related symptoms as evidenced by at least 25% 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 Outcome Measures

Functionality (Stage 1) - Location and orientation of Omega implant in the prostate before prostatectomy is as planned: Yes/No
Evaluating whether the outcome of the Omega implant's location and orientation turned out as the surgeon planned prior to the Omega procedure.
Functionality (Stage 1) - Location and depth Omega incision in the excised prostate is as planned: Yes/No.
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
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
Evaluate the improvement in urinary-related symptoms as evidenced by a decrease of at least 25% 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
Exploratory - Change in PSA
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).
The IIEF-5 score ranges from 5 to 25 and is used to classify erectile dysfunction (ED) into five categories based on the scores: no ED (22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7). 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
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.
Exploratory - Change in post-void residual (PVR) test
Exploratory - Incidence of inflammation, assessed by cystoscope
Exploratory - Omega coverage assessed by cystoscope

Full Information

First Posted
February 15, 2023
Last Updated
March 8, 2023
Sponsor
ProArc Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05757687
Brief Title
Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH
Acronym
Omega
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProArc Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega procedure
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Omega device
Intervention Description
The ProArc Medical Omega system is a prostatic reshaping device. The Omega System is comprised of two main components: Omega Delivery Device and Omega g 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.
Primary Outcome Measure Information:
Title
Primary Safety (Stage 1 and Stage 2) - Incidence and severity of procedural and device related adverse events.
Description
Incidence and severity of procedural and device related adverse events.
Time Frame
12 Months
Title
Primary Safety (Stage 2) - Incidence of post-operative catheterization after 7 days, up to 14 days.
Description
Incidence of post-operative catheterization after 7 days, up to 14 days.
Time Frame
2 weeks
Title
Efficacy (Stage 2) - Change in urinary related symptom
Description
Improvement in urinary related symptoms as evidenced by at least 25% 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)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Functionality (Stage 1) - Location and orientation of Omega implant in the prostate before prostatectomy is as planned: Yes/No
Description
Evaluating whether the outcome of the Omega implant's location and orientation turned out as the surgeon planned prior to the Omega procedure.
Time Frame
Procedure day
Title
Functionality (Stage 1) - Location and depth Omega incision in the excised prostate is as planned: Yes/No.
Description
Evaluating whether the Omega incision location and depth outcome turned out as the surgeon planned prior to the Omega procedure.
Time Frame
Procedure day
Title
Usability (Stage 1 and Stage 2) - Evaluate the usability of the device and entire process
Description
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)
Time Frame
Procedure day
Title
Efficacy (Stage 2) - Improvement in urinary related symptoms
Description
Evaluate the improvement in urinary-related symptoms as evidenced by a decrease of at least 25% in the IPSS score. (A score of 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms and 20-35 indicates severe symptoms)
Time Frame
1 Months, 6 Months and 12 months
Title
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
Title
Exploratory - Change in PSA
Time Frame
1 Months, 6 Months and 12 Months
Title
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).
Description
The IIEF-5 score ranges from 5 to 25 and is used to classify erectile dysfunction (ED) into five categories based on the scores: no ED (22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7). An MSHQ-EjD score of 20 indicates the absence of ejaculatory dysfunction, while a score of 0 indicates a high level of ejaculatory dysfunction.
Time Frame
3 Months, 6 Months and 12 months
Title
Exploratory - Change in VAS pain score
Description
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.
Time Frame
1-2 weeks and 1 month
Title
Exploratory - Change in post-void residual (PVR) test
Time Frame
1 Months, 3 Months, 6 Months and 12 months
Title
Exploratory - Incidence of inflammation, assessed by cystoscope
Time Frame
6 months
Title
Exploratory - Omega coverage assessed by cystoscope
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 of age and ≤ 80 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-α-reductase inhibitors within 6 months of pre-treatment (baseline) evaluation. 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 and 5-α-reductase.] 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). Intravesical lobe (if approved by prior cystoscopy). Obstructive 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. Diagnosed with Chronic Pelvic Pain Syndrome (CPPS). Previous rectal surgery, other than hemorrhoidectomy. Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%). Known allergy to nickel or titanium or stainless steel.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fay Dan
Phone
972-544-781-599
Email
fay@proarcmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Mastandrea, Dr
Organizational Affiliation
Board Member and Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
JSC L.Managadze National Center of Urology
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeri Shtaadze, Dr
Email
vshtaadze@gmail.com
First Name & Middle Initial & Last Name & Degree
Ambrosi Pertia, Dr
Facility Name
Todua Clinic
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nino Batselashvili, Dr
Email
Ninobatselashvili@gmail.com
First Name & Middle Initial & Last Name & Degree
Zaal Kvirikashvili, Dr
First Name & Middle Initial & Last Name & Degree
Kakha Barnovi, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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