Health Trials

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

Qualifiers

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

Treatments tested in this trial

  • Omega

Treatment groups

26 Participants
are divided into 1 treatment group

Locations

4
Israel
Soroka Medical Center Beersheba Israel
Carmel Medical Center Haifa Israel
Rambam Health Care Campus Haifa Israel
New Zealand
Tauranga Urology Research Limited Tauranga New Zealand

Sponsors and collaborators

ProArc Medical

Lead sponsor

Source ClinicalTrials.gov