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

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.

Study Overview

• Status: Completed
• Conditions: Benign ProstaticHyperplasia (BPH)
• Intervention / Treatment: Device: ClearRing™

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of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn.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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam MC
• Latvia
  • Riga, Latvia
    • Department of Urology, Pauls Stradins Clinical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ClearRing™; 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™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The frequency and severity of all treatment-related adverse events	up to 3 months after procedure day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Qmax	measured by Uroflowmetry	change from baseline until 3 months FU visit
Changes in Post Void Residual	measured by Ultra-Sound	change from baseline until 3 months FU visit
Changes in LUTS symptoms	evaluated by patient's questionnaires (IPSS)	change from baseline until 3 months FU visit
Changes in LUTS symptoms	evaluated by patient's questionnaires ( BPHII)	change from baseline until 3 months FU visit
Changes in LUTS symptoms	evaluated by patient's questionnaires ( IIEF)	change from baseline until 3 months FU visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Catheter use post procedure		until 12 months post procedure
Long term safety evaluation	AE collection	until 12 months post procedure

Collaborators and Investigators

• Sponsor: ProArc Medical

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 20, 2015
• First Posted (Estimate): December 24, 2015

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: PA-CP-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED