Trials / Recruiting
RecruitingNCT04627701
Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
Evaluation of the Safety and Efficacy of the Omega System for the Treatment of Benign Prostatic Hyperplasia
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- Sponsor
- ProArc Medical · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Omega | Omega Implantation |
Timeline
- Start date
- 2023-07-23
- Primary completion
- 2026-01-01
- Completion
- 2026-08-01
- First posted
- 2020-11-13
- Last updated
- 2025-08-07
Locations
4 sites across 2 countries: Israel, New Zealand
Source: ClinicalTrials.gov record NCT04627701. Inclusion in this directory is not an endorsement.