Benign ProstaticHyperplasia (BPH) Clinical Trial
Official title:
Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
| NCT number | NCT02639442 |
| Other study ID # | PA-CP-10 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2015 |
| Est. completion date | May 2019 |
| Verified date | March 2023 |
| Source | ProArc Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | May 2019 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 50 Years to 85 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rambam MC | Haifa | |
| Latvia | Department of Urology, Pauls Stradins Clinical University Hospital | Riga |
| Lead Sponsor | Collaborator |
|---|---|
| ProArc Medical |
Israel, Latvia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Duration of Catheter use post procedure | until 12 months post procedure | ||
| Other | Long term safety evaluation | AE collection | until 12 months post procedure | |
| Primary | The frequency and severity of all treatment-related adverse events | up to 3 months after procedure day | ||
| Secondary | Changes in Qmax | measured by Uroflowmetry | change from baseline until 3 months FU visit | |
| Secondary | Changes in Post Void Residual | measured by Ultra-Sound | change from baseline until 3 months FU visit | |
| Secondary | Changes in LUTS symptoms | evaluated by patient's questionnaires (IPSS) | change from baseline until 3 months FU visit | |
| Secondary | Changes in LUTS symptoms | evaluated by patient's questionnaires ( BPHII) | change from baseline until 3 months FU visit | |
| Secondary | Changes in LUTS symptoms | evaluated by patient's questionnaires ( IIEF) | change from baseline until 3 months FU visit |