Back to resultsCLEAR Study: Evaluation of the Safety and Efficacy of the ClearRing System for the Treatment of BPH
Primary Purpose
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ClearRing
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Male ≥45 years of age and ≤ 75 years old
- Diagnosed with symptomatic benign prostatic hyperplasia (BPH)
- International Prostate Symptom Score (IPSS) >13
- Participant understands and is willing to sign the informed consent form
Exclusion Criteria:
- Significant comorbidities which would affect study participation.
- Diagnosed or suspected prostate cancer.
- Active Urinary Tract Infection (UTI)
- Concomitant bladder or kidney stones
- Confirmed or suspected malignancy of bladder
- History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms
- Bacterial prostatitis
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ClearRing Device
Arm Description
Outcomes
Primary Outcome Measures
Improvement in urinary related symptoms as evidenced by IPSS score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04627701
Brief Title
CLEAR Study: Evaluation of the Safety and Efficacy of the ClearRing System for the Treatment of BPH
Official Title
Evaluation of the Safety and Efficacy of the ClearRing System for the Treatment of Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProArc Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
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 electrocutting blade to perform a circular incision, in which the implant is placed. The implant expands the obstructed area, and allows fluid flow through the prostatic urethra
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ClearRing Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ClearRing
Intervention Description
ClearRing Implantation
Primary Outcome Measure Information:
Title
Improvement in urinary related symptoms as evidenced by IPSS score
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male ≥45 years of age and ≤ 75 years old
Diagnosed with symptomatic benign prostatic hyperplasia (BPH)
International Prostate Symptom Score (IPSS) >13
Participant understands and is willing to sign the informed consent form
Exclusion Criteria:
Significant comorbidities which would affect study participation.
Diagnosed or suspected prostate cancer.
Active Urinary Tract Infection (UTI)
Concomitant bladder or kidney stones
Confirmed or suspected malignancy of bladder
History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms
Bacterial prostatitis
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
CLEAR Study: Evaluation of the Safety and Efficacy of the ClearRing System for the Treatment of BPH
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