Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia

NCT02639442 | Completed

• 1 other identifier: PA-CP-10
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 2

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.

Conditions

Benign ProstaticHyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

• The frequency and severity of all treatment-related adverse events

  up to 3 months after procedure day

Secondary Outcomes (5)

• Changes in Qmax

  change from baseline until 3 months FU visit

• Changes in Post Void Residual

  change from baseline until 3 months FU visit

• Changes in LUTS symptoms

  change from baseline until 3 months FU visit

• Changes in LUTS symptoms

  change from baseline until 3 months FU visit

• Changes in LUTS symptoms

  change from baseline until 3 months FU visit

Other Outcomes (2)

• Duration of Catheter use post procedure

  until 12 months post procedure

• Long term safety evaluation

  until 12 months post procedure

Study Arms (1)

ClearRing™

EXPERIMENTAL

subjects will undergo general/spinal/local block anesthesia and cystoscopy and/or x-ray evaluation. One to three implants will be transplanted into the patient prostate, followed by cystoscopy for results evaluation

Device: ClearRing™

Interventions

ClearRing™ DEVICE

ClearRing™

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male 50 years of age and up to 85 years old.
• Diagnosed with symptomatic benign prostatic hyperplasia (BPH)
• International Prostate Symptom Score (IPSS) \>13
• Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml)
• Subject is in good general health.
• Subject understands and has signed the study informed consent form.
• PSA according to the American Urological Association) AUA) guideline.

You may not qualify if:

• Subjects who are known to be infected with Hepatitis B, Hepatitis C, or HIV viruses.
• Subject allergic to nickel or titanium
• Concomitant participation in another study
• Diagnosed with Cancer except of BCC or SCC of the skin
• Any medical condition at the investigator discretion that may interfere with the procedure.
• Patient with coagulopathy due to medications or congenital
• Patient is taking steroids
• Previous prostate surgery
• Compromised renal function due to obstructive uropathy
• Urinary Tract Infection (UTI)
• Intravesical lobe (based on ultrasound and/or cystoscopy and/or medical history)
• Prostate volume (based on Trans Rectal Ultrasound) \> 80g
• American Society of Anesthesiologists score (ASA)≥3
• Known neurogenic bladder
• Implanted electronic device such as pacemaker/CRT/ICD/DBS.

Sponsors & Collaborators

• ProArc Medical: lead

Study Sites (2)

Rambam MC

Haifa, Israel

Location

Department of Urology, Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 24, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: May 1, 2019
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

LA (1); IL (1)