Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorProArc Medical
About this trial
The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male ≥50 years of age
Diagnosed with symptomatic benign prostatic hyperplasia (BPH).
International Prostate Symptom Score (IPSS) >13.
Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Omega
DeviceOmega Implantation
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: Omega DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Improvement in urinary related symptoms as evidenced by IPSS score
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov