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
Qualifiers
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
Treatments tested in this trial
- Omega device
Treatment groups
11 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov