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

NCT ID: NCT02639442

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-05-31

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of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn.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

Conditions

Benign ProstaticHyperplasia (BPH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ClearRing™

Intervention Type: DEVICE

Interventions

ClearRing™

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ProArc Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rambam MC

Haifa, , Israel

Department of Urology, Pauls Stradins Clinical University Hospital

Riga, , Latvia

Countries

Israel; Latvia

Other Identifiers

PA-CP-10

Identifier Type: -

Identifier Source: org_study_id