- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04627701
Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
November 20, 2023 updated by: ProArc Medical
Evaluation of the Safety and Efficacy of the Omega System for the Treatment of Benign Prostatic Hyperplasia
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fay Dan
- Phone Number: +972 54-478-1599
- Email: Fay@proarcmedical.com
Study Contact Backup
- Name: Gilad Hizkiyahu
- Phone Number: +972 52-241-5544
- Email: gilad@proarcmedical.com
Study Locations
-
-
-
Be'er Sheva, Israel
- Recruiting
- Soroka Medical Center
-
Contact:
- Victoria Davidov
- Phone Number: +972-8-6245287
- Email: victoriadav@clalit.org.il
-
Principal Investigator:
- Nicola Mabjeesh, Prof
-
Haifa, Israel
- Recruiting
- Carmel Medical Center
-
Contact:
- Inna Kogan
- Phone Number: 04-8844415
- Email: InnaKog@clalit.org.il
-
Principal Investigator:
- Yoram Dekel, Dr
-
Haifa, Israel
- Not yet recruiting
- Rambam Health Care Campus
-
Contact:
- Alexander Kravtsov, Dr
- Email: A_KRAVTSOV@rambam.health.gov.il
-
Principal Investigator:
- Kravtsov
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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).
- Participant understands and is willing to the informed consent form.
- Prostate Volume between 30cc and 80cc.
- Prostate length ≥3cm and ≤5cm
Exclusion Criteria:
- 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.
- Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as:
- Use of concomitant medications (e.g., anticholinergics, antispasmodics, or antidepressants) affecting bladder function.
- 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 not prohibited.
- Alpha-blockers within 2 weeks of pre-treatment (baseline) evaluation.
- Taking 5-alpha reductase inhibitors (5-ARI) within 6 months (3 months for type II 5-ARI) of pre-treatment (baseline) evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued throughout the study).
- Patient is taking steroids. [Note: Patients approved for the trial who are using the above medications will continue using them after the trial, except for Alpha blockers]
- Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
- Compromised renal function due to obstructive uropathy.
- Active Urinary Tract Infection (UTI).
- Obstructive or protruding median lobe
- American Society of Anaesthesiologists score (ASA) > 3.
- Known neurogenic bladder or neurological disorders that might affect bladder or function.
- Recent myocardial infarction (less than three months).
- Concomitant bladder stones.
- Current gross hematuria.
- Active or history of epididymitis within the past 3 months.
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
- Confirmed or suspected malignancy of bladder.
- History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms.
- Other Urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
- Bacterial prostatitis within the last 12 months.
- Previous rectal surgery, other than hemorrhoidectomy.
- Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%).
- Known allergy to nickel or titanium or stainless steel.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omega Device
|
Omega Implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in urinary related symptoms as evidenced by IPSS score
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 23, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 8, 2020
First Submitted That Met QC Criteria
November 8, 2020
First Posted (Actual)
November 13, 2020
Study Record Updates
Last Update Posted (Actual)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA-CP-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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