Benign ProstaticHyperplasia (BPH)
Conditions
Brief summary
The ProArc Medical ClearRing™ 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 an electro-cutting blade to perform a circular and superficial incision, in which the implant is placed. Such an implant, with the shape of an open ring, expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.
Detailed description
The proposed study will be conducted on BPH patients, candidates for TURP and will aim to evaluate the ability of the ClearRing™ to improve BPH symptoms while conforming to safety of the procedure. In the proposed study the implants will be inserted by a dedicated delivery system with the aid of resectoscope. Electrical current will be administered by off-the-shelf CE Mark diathermy that passes through the system to cut and pave the ring course. The proper positioning of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn. The delivery tool, the implants, resectoscope and the diathermy equipment will be supplied by ProArc Ltd.
Interventions
DEVICEClearRing™
Sponsors
ProArc Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male 50 years of age and up to 85 years old. 2. Diagnosed with symptomatic benign prostatic hyperplasia (BPH) 3. International Prostate Symptom Score (IPSS) \>13 4. Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml) 5. Subject is in good general health. 6. Subject understands and has signed the study informed consent form. 7. PSA according to the American Urological Association) AUA) guideline.
Exclusion criteria
1. Subjects who are known to be infected with Hepatitis B, Hepatitis C, or HIV viruses. 2. Subject allergic to nickel or titanium 3. Concomitant participation in another study 4. Diagnosed with Cancer except of BCC or SCC of the skin 5. Any medical condition at the investigator discretion that may interfere with the procedure. 6. Patient with coagulopathy due to medications or congenital 7. Patient is taking steroids 8. Previous prostate surgery 9. Compromised renal function due to obstructive uropathy 10. Urinary Tract Infection (UTI) 11. Intravesical lobe (based on ultrasound and/or cystoscopy and/or medical history) 12. Prostate volume (based on Trans Rectal Ultrasound) \> 80g 13. American Society of Anesthesiologists score (ASA)≥3 14. Known neurogenic bladder 15. Implanted electronic device such as pacemaker/CRT/ICD/DBS. 16. Recent myocardial infarction (less than three months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency and severity of all treatment-related adverse events | up to 3 months after procedure day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Qmax | change from baseline until 3 months FU visit | measured by Uroflowmetry |
| Changes in Post Void Residual | change from baseline until 3 months FU visit | measured by Ultra-Sound |
| Changes in LUTS symptoms | change from baseline until 3 months FU visit | evaluated by patient's questionnaires (IPSS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of Catheter use post procedure | until 12 months post procedure | — |
| Long term safety evaluation | until 12 months post procedure | AE collection |
Countries
Israel, Latvia
Outcome results
None listed