Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorProArc Medical
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Unable to comply with the clinical protocol.
Vulnerable population such as inmates or developmentally delayed individuals.
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.
Trial design
Design model
Single group
Treatments tested in this trial
Omega device
DeviceThe 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.
Treatment groups
11 Participants
are divided into 1 treatment groupGroup A: Omega procedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 Months2
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.
Time frame
2 weeks3
Efficacy (Stage 2) - Change in urinary related symptom
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)
Time frame
3 MonthsSecondary outcomes
1
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.
Time frame
Procedure day2
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.
Time frame
Procedure day3
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)
Time frame
Procedure day4
Efficacy (Stage 2) - Improvement in urinary related symptoms
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)
Time frame
1 Months, 6 Months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov