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OpenTrials
Completed

NCT Number: NCT02639442

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.

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Key information

Conditions

Benign ProstaticHyperplasia (BPH)

Age range

50 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rambam MC, Haifa, Israel

Loading trial locations.

About this study

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of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Recent myocardial infarction (less than three months)

Treatment and study plan

ClearRing™

Device

Primary outcomes

  1. The frequency and severity of all treatment-related adverse events

    Time frame: up to 3 months after procedure day

Secondary outcomes

  1. Changes in Qmax

    Time frame: change from baseline until 3 months FU visit

    measured by Uroflowmetry

  2. Changes in Post Void Residual

    Time frame: change from baseline until 3 months FU visit

    measured by Ultra-Sound

  3. Changes in LUTS symptoms

    Time frame: change from baseline until 3 months FU visit

    evaluated by patient's questionnaires (IPSS)

  4. Changes in LUTS symptoms

    Time frame: change from baseline until 3 months FU visit

    evaluated by patient's questionnaires ( BPHII)

  5. Changes in LUTS symptoms

    Time frame: change from baseline until 3 months FU visit

    evaluated by patient's questionnaires ( IIEF)

Other outcomes

  1. Duration of Catheter use post procedure

    Time frame: until 12 months post procedure

  2. Long term safety evaluation

    Time frame: until 12 months post procedure

    AE collection

Sponsors and collaborators

Lead sponsor

ProArc Medical

Industry

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Dec 24, 2015
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.