Back to resultsClinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
Primary Purpose
Benign ProstaticHyperplasia (BPH)
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ClearRing™
Sponsored by
About this trial
This is an interventional treatment trial for Benign ProstaticHyperplasia (BPH)
Eligibility Criteria
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)
Sites / Locations
- Rambam MC
- Department of Urology, Pauls Stradins Clinical University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ClearRing™
Arm Description
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
Outcomes
Primary Outcome Measures
The frequency and severity of all treatment-related adverse events
Secondary Outcome Measures
Changes in Qmax
measured by Uroflowmetry
Changes in Post Void Residual
measured by Ultra-Sound
Changes in LUTS symptoms
evaluated by patient's questionnaires (IPSS)
Changes in LUTS symptoms
evaluated by patient's questionnaires ( BPHII)
Changes in LUTS symptoms
evaluated by patient's questionnaires ( IIEF)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02639442
Brief Title
Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProArc Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign ProstaticHyperplasia (BPH)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ClearRing™
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
ClearRing™
Primary Outcome Measure Information:
Title
The frequency and severity of all treatment-related adverse events
Time Frame
up to 3 months after procedure day
Secondary Outcome Measure Information:
Title
Changes in Qmax
Description
measured by Uroflowmetry
Time Frame
change from baseline until 3 months FU visit
Title
Changes in Post Void Residual
Description
measured by Ultra-Sound
Time Frame
change from baseline until 3 months FU visit
Title
Changes in LUTS symptoms
Description
evaluated by patient's questionnaires (IPSS)
Time Frame
change from baseline until 3 months FU visit
Title
Changes in LUTS symptoms
Description
evaluated by patient's questionnaires ( BPHII)
Time Frame
change from baseline until 3 months FU visit
Title
Changes in LUTS symptoms
Description
evaluated by patient's questionnaires ( IIEF)
Time Frame
change from baseline until 3 months FU visit
Other Pre-specified Outcome Measures:
Title
Duration of Catheter use post procedure
Time Frame
until 12 months post procedure
Title
Long term safety evaluation
Description
AE collection
Time Frame
until 12 months post procedure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Rambam MC
City
Haifa
Country
Israel
Facility Name
Department of Urology, Pauls Stradins Clinical University Hospital
City
Riga
Country
Latvia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Study for the Evaluation of the Safety and Initial Performance of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
We'll reach out to this number within 24 hrs