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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639442
Recruitment Status : Unknown
Verified September 2016 by ProArc Medical.
Recruitment status was:  Recruiting
First Posted : December 24, 2015
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
ProArc Medical

Study Description
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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.


Condition or disease Intervention/treatment Phase
Benign ProstaticHyperplasia (BPH) Device: ClearRing™ Phase 1 Phase 2

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of the implants will be evaluated by cystoscopy or TRUS and following implant positioning the device will be withdrawn.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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
Study Start Date : December 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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™


Outcome Measures
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Primary Outcome Measures :
  1. The frequency and severity of all treatment-related adverse events [ Time Frame: up to 3 months after procedure day ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639442


Contacts
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Contact: Shai Golan SHAI@PROARCMEDICAL.COM

Locations
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Israel
Rambam MC Recruiting
Haifa, Israel
Naharia MC Recruiting
Naharia, Israel
Sponsors and Collaborators
ProArc Medical
More Information
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Responsible Party: ProArc Medical
ClinicalTrials.gov Identifier: NCT02639442    
Other Study ID Numbers: PA-CP-10
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases